Director, Quality (Health Hazard backssments)

Detailed Information

LISTED SITE
  • Location: Center Valley, PA

  • Company: Olympus

lives healthier, safer, and more fulfilling. Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View We deliver on our purpose and our core values by staying True to Life. Job Description The Director, Health Hazard backssment shall have direct leadership, accountability, and oversight of the Health Hazard backssment (HHA) process.

The Director will, working with others, provide primary support for HHA activities to ensure Olympus develops data driven HHAs with robust issue analysis, and justified conclusions and summaries. The position is responsible for developing and implementing programs and policies to ensure HHA development and backssments

occurs in a timely manner to address safety and compliance areas of our business and to ensure proper documentation are in place. This position will be support and train Olympus resources to gain required HHA analysis and documentation skills and aligned to regulatory expectations.

Serves as primary subject matter expert for regulatory inspections, regulatory inquiries, and 3rd party audits. Job Duties Manages day-to-day operation of the global HHA Program. Ensure HHA deadlines are achieved and establish and meet key performance indicators. Maintain current knowledge of industry best practices and regulatory requirements as well as Olympus operations across the areas of HHAs and Field

Actions, complaint handling, adverse event reporting, CAPA and Post Market Surveillance activities in support of HHA development and expert guidance for the HHA teams.

Apply knowledge to develop processes, optimize processes, and suggest improvement to current processes as needed. Develops, initiates, maintains, and revises policies and procedures for the HHA Program and related activities in line with regulatory expectations. Works to prevent, detect, and correct compliance risks through designing, implementing, and monitoring policies, procedures, and internal controls related to respective compliance requirements in coordination with management and other parties.

Manages, oversees, provides guidance and assists HHA Owners, providing consultation and recommendations on relevant product quality issues affecting the organization. Day-to-day leader for the global HHA teams to aid in resolution of challenging and complex issues and removal of barriers to ensure timely and complete HHAs. Escalates to Global VP, Field Actions. Responsible for successful preparation and timely distribution of completed HHAs to the Field Corrective Action (FCA) Review Board for FCA voting. Responsible for working in partnership with Medical Safety, Regulatory, Complaint, CAPA, and Non- Conforming teams to identify, document and escalate, where necessary, situations requiring HHA analysis.

Collaborates with global/regional leaders on relevant HHAs and interacts with Legal and Compliance as required. Supports HHA inspections and is key internal HHA inspection leader in support of regulatory inspections. •Identify and lead decision making and escalation of fast track issues for immediate evaluation and decision making. Identify and manage internal and external resources, as necessary, to support the global HHA program and HHA teams. Job Requirements A minimum of a 4-year college degree (Bachelor’s Degree) in engineering or scientific discipline is required.

Master’s Degree or equivalent is preferred, with preferred areas of study being in the Scientific or Engineering discipline 10+ years of professional experience in a medical device safety management role is required Demonstrated experience in developing and leading a top performing quality team is required. Proficient understanding of medical device regulations which include recalls/FCAs, complaint handling, and adverse event reporting is required. Strong analytical, organizational and communication skills required.

Why join Olympus? Here, people matter—our health, our happiness, and our lives. Competitive salaries, annual bonus and 401(k) with company match Comprehensive Medical, Dental, Visions coverage effective on start date 24/7 Employee Assistance Program Free virtual live and on-demand wellness classes Work-life balance supportive culture with hybrid and remote roles 12 Paid Holidays Educational Assistance Parental Leave and Adoption Assistance Volunteering and charitable donation match programs Diversity & Inclusion Programs including Colleague Affinity Networks On-Site Child Daycare, Café, Fitness Center US Only Limited locations We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you.

Learn more about our benefit offerings at /careers/benefits-perks. About us: Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit . Olympus is dedicated to building a diverse, inclusive and authentic workplace We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect.

We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive. Let’s realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, interaction (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, interactionual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: United States (US) Pennsylvania (US-PA) Center Valley

Management & Executive in Bethlehem, PA

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network, regulatory, and third party standards. Supports and supervises clinical staff in patient care operations including initial backssment, treatment planning, therapeutic interventions, crisis intervention, coordination of care, and discharge planning.

Supports program development, access enhancement, performance Improvement, utilization review, service recovery, and safety activities. Supports effective revenue cycle activities and, as necessary, clerical operations in the program. Supports the development and management of effective recruitment, orientation, education, competency, performance evaluation, and staff satisfaction of clinical personnel. Supports accurate, timely, and

appropriate documentation in clinical activities with patients. Supports linkages with other departmental programs, network departments, and community programs; engages in program promotion both within LVHN and the community at large.

Minimum Qualifications Master's Degree in Social Work, Counseling, or related clinical field. 3 years clinical experience in a mental health setting with history of demonstrated skills in supervisory or administrative activities. Demonstrated clinical, supervisory, and administrative skills. Ability to work within a multidisciplinary team. Licensed Clinical Social Worker Required in Outpatient (except LCSW mandatory in Mental Health Clinics) Upon Hire or

Licensed Professional Counselor Required in Outpatient (except LPC ineligible for Mental Health Clinics) Upon Hire Physical Demands Lift and carry 25 lbs.

frequent sitting/standing, frequent keyboard use, patient care providers may be required to perform activities specific to their role including kneeling, bending, squatting and performing CPR. Job Description Disclaimer: This position description provides the major duties/responsibilities, requirements and working conditions for the position. It is intended to be an accurate reflection of the current position, however management reserves the right to revise or change as necessary to meet organizational needs. Other responsibilities may be assigned when circumstances require.

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Bethlehem, PA
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lives healthier, safer, and more fulfilling. Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View We deliver on our purpose and our core values by staying True to Life. Job Description Seeking a Security Architecture Lead to support the Olympus cybersecurity mission.

Looking for a senior security architecture cyber-professional to help solution, lead against an ever-evolving cyber threat landscape, and protect critical information assets within the Healthcare and Manufacturing Industry. The Security Architecture Lead sets security architecture strategy in collaboration with the IT Security Head and executes the strategy through oversight of

Olympus security architecture personnel and managed service providers. This position is responsible for ensuring the secure design and compliance of enterprise architecture to effectively and securely support the organization in meeting specific business technology needs.

This candidate will lead architecture design reviews to evaluate security controls and identify opportunities to enhance the security posture of the Olympus business environments, build relationships with infrastructure architects and engineering leads to disseminate and explain secure design methodologies and policies. Ideal candidates will also understand the landscape and components of cutting-edge architectures and

the methods to securely deploy them. In addition, this position will partner with a region and be the key contact for the regional CIO and local business.

They will be the point person for coordinating any necessary regional incidents, information security & privacy meetings and ensure any regional needs are addressed appropriately with the IT Security team. They will facilitate understanding of local/regional laws and regulations that need to be followed. Job Duties Define and review Olympus security architecture strategy, architecture, processes and controls. Identify and define architecture security requirements by evaluating Olympus business strategies and requirements.

Communicate with managed service provider security architecture lead(s) and Olympus regional teams about process, people and technology requirements and changes related to Olympus. Review and approve the HLD and LLD security architecture requirements for LANs, WANs, VPNs, routers, firewalls, and other security tools including cloud infra designed or managed by managed service providers at a global level. Review proof of concept results and security architecture for any proposed or pipeline security solution along with managed service provider security architecture lead(s).

Lead the adoption of security architecture initiatives in order to effectively and securely support the organization in meeting specific business technology needs. Drive consideration of cybersecurity tools and datasets to enhance detective and preventative control sets. Execute and improve on Olympus’ Security architecture review process and ensure compliance for all business initiatives. Architect global programs that deploy strong security patterns and controls across applications and computing environments, while addressing security, business resiliency, privacy and compliance frameworks.

Validate reference architectures for security best practices and recommend changes to enhance security and reduce risk, where applicable. Partner with a regional CIO to be key contact for security initiatives, understanding and supporting regional business requirements and represent the global security team in Information Security & Privacy and other business meetings. Oversee Security Architecture Projects in all regions (across sales, enterprise, and manufacturing environments. Interview and hire Security Architecture Sr. Security Architects across regions to serve as the Security Architecture operational team in collaboration with managed service providers.

Overseeing Security Architecture full-time personnel, part-time personnel, and third-party service providers. Other responsibilities / duties as assigned. Job Qualifications Required: A minimum of a Bachelor’s degree in IT/ Information Systems/ Business/ Technology. Should hold at least one of the major security certifications (ex: CISM, CISSP, CISA, CRISC, CCSP, CISSP-ISSAP, GPEN, GICSP, GRID, SABSA, CNDA, CRTSA, GDSA etc Minimum of 10 years of Leadership and/ or Management experience. At least 10 years of experience with: Securing traditional enterprise IT, manufacturing, and cloud infrastructure.

Evaluating and implementing security technologies. Defining security requirements to secure enterprise infrastructure. Implementing and operating secure architectures through people, process and technology controls. Internally and externally recognized subject matter expert that influence the way things are done. Demonstrated consulting skills, with IT Security concepts and strategies, including communication, culture change and performance measurement system design. Preferred: Embrace and lead change effectively and cultivate an environment of security driven thinking, innovation, experimentation, rigor and continuous improvement.

Results oriented, high energy, inspirational and self-motivated leader. Strong interpersonal and motivational skills. Strong analytical skills. Excellent written, verbal communication and presentation skills with ability to effectively communicate with leadership team. Multilingual communication preferred. Why join Olympus? Here, people matter—our health, our happiness, and our lives. Competitive salaries, annual bonus and 401(k) with company match Comprehensive Medical, Dental, Visions coverage effective on start date 24/7 Employee Assistance Program Free virtual live and on-demand wellness classes Work-life balance supportive culture with hybrid and remote roles 12 Paid Holidays Educational Assistance Parental Leave and Adoption Assistance Volunteering and charitable donation match programs Diversity & Inclusion Programs including Colleague Affinity Networks On-Site Child Daycare, Café, Fitness Center US Only Limited locations We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you.

Learn more about our benefit offerings at /careers/benefits-perks. About us: Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.

For more information, visit . Olympus is dedicated to building a diverse, inclusive and authentic workplace We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive. Let’s realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, interaction (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, interactionual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: United States (US) Pennsylvania (US-PA) Center Valley Information Technology (IT)

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degree from an accredited institution Desire and willingness to learn multiple facets of the business Ability to travel overnight, less than 10% What you will earn: Competitive base pay Medical, dental, and vision benefits 401(k) match Paid leave including parental leave, sick leave, and paid time off Paid training and advancement opportunities If you’re good at what you do, you can work anywhere.

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yet always encouraging. Each shift is a new opportunity to Discover Different. Posting Notes: TJ Maxx Store 0421 2631 Macarthur Rd Whitehall PA 18052 Opportunity: Contribute To The Growth Of Your Career. Responsible for executing receiving and merchandising standards while ensuring Associates are processing efficiently and effectively, and working as a team.

Ensures an excellent customer experience by engaging and interacting with all customers, and maintaining a clean and organized store. Role models exceptional customer service Creates a positive internal and external customer experience Promotes a culture of honesty and integrity; maintains confidentiality Orchestrates truck delivery,

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Maintains all organizational, cleanliness and recovery standards for the backroom area according to established company procedures Ensures compliance with recycling and, where applicable, hazardous waste programs Communicates accurately and effectively with management and Associates when setting and addressing priorities; provides periodic progress updates Provides and accepts ongoing recognition and constructive feedback Partners with Management on Associate training needs to increase effectiveness Ensures adherence to all labor laws, policies, and procedures Promotes credit and loyalty programs during customer interactions Supports and participates in store shrink reduction goals and programs Promotes safety awareness and supports maintenance of a risk-free environment Performs other duties as assigned Who We Are Looking For: You!

Able to work a flexible schedule to support business needs, including nights and weekends Superior organizational skills with attention to detail Capable of handling multiple tasks at one time Ability to respond appropriately to changes in direction or unexpected situations Team player, working effectively with peers and supervisors to accomplish tasks Capable of lifting heavy objects with or without reasonable accommodation Strong communication skills Ability to train others One year retail and 6 months of leadership experience A Few More Reasons to Love TJX.

Competitive Compensation Weekly Paychecks Associate Discount Career development opportunities TAAP – TJX Associate Assistance Programs Be a part of an inclusive team Flexible work schedules Benefit programs and eligibility terms vary across our global locations. We encourage you to apply to learn more about how our benefits can make a difference for you. At TJ Maxx there’s so much potential to discover something new. A new day means new merchandise, and a fresh chance to reinvent retail.

Discover Different means that we want you to bring your whole self and your sense of style to work with you every day - just as Associates do throughout the entire TJX family, which includes Marshalls, Home Goods, Sierra, and Homesense. Discover Different also means we embrace each other’s differences and unique perspectives. We consider all applicants for employment without regard to race, color, religion, gender, interactionual orientation, national origin, age, disability, gender identity and expression, marital or military status. We also provide reasonable accommodations to qualified individuals with disabilities in accordance with the Americans with Disabilities Act and applicable state and local law.

Posting Notes: TJ Maxx Store 0421 2631 Macarthur Rd Whitehall PA 18052

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