discipline. Experience must include two (2) years of post-bachelor's progressive experience in all of the following: ISO 9001:2015 internal auditor certification or equivalent/similar regulatory compliance certification in FDA or medical or aerospace. Verify and validate New Product introductions through first article review.
Support Monthly Supplier Evaluations by gathering and presenting appropriate data. S upport supplier product qualification through first article. Identify failure trends and drive investigation, Root Cause analysis, and Corrective Actions. Strong understanding of Quality concepts and tools, such as SPC, Corrective Action Investigation, Lean Manufacturing, 6S, Six
Sigma, FMEA. Implement process changes in documentation and record control. Support manufacturing and Operations engineering with production issues. Proficient in Microsoft Office.
Please send resumes to xyz X@ " Refer to job Quality Engineer. Must have the legal authority to work in the US. EOE. Job Posted by Applicant Pro
including data acquisition and control, data analysis, etc. As the Software Quality Engineer, you will make your mark by championing software quality best practices and leading Headwall's software quality efforts for all software products. You will design and create our build and test infrastructure.
You will collaborate with software developers and subject matter experts (SMEs) to ensure that we deliver quality software that delights our customers. Roles & Responsibilities: Lead software quality efforts for all software products Develop comprehensive test plans for all software products Develop our build and test automation infrastructure Create build automation for our existing and
next-generation software components and applications Create test automation for our next-generation software components and applications Perform manual testing as required to ship quality software Provide leadership and expertise to help us incorporate software best practices into Headwall's software development process Knowledge and Skills: Required: Expertise creating test plans based on functional requirements Expertise creating build and test automation Demonstrated success testing C++ API libraries Knowledge of Windows and Linux Strong organizational skills (time management and planning) and attention to detail Ability to thrive in a fast-paced, dynamic team environment Excellent oral and
written communication skills Desired: Programming in C++/C# or Python Knowledge of GUI test automation Knowledge of Web Socket protocol Experience and Education: Required: Bachelor's degree in Computer Science or related field 5 to 10 years of experience in Software Quality working in a challenging technical domain Desired: Experience with acquisition software interfacing with camera, GPS, and Li DAR devices and other embedded systems Experience with analysis software involving technical computing and algorithms Experience with test station software (device testing using data acquisition and control) Experience with hyperspectral imaging systems Additional experience in functional areas outside of quality (e.
g. Engineering, Software Development) FAA-Certified Drone Pilot Headwall Photonics Offers: Outstanding benefits package (including medical, dental, vision, life insurance) 401(k) plan with matching company contribution Generous holiday and paid time off schedules In-office/remote hybrid work schedule Relocation assistance available Headwall Photonics, Inc. is an Affirmative Action and Equal Opportunity employer. We solicit and hire applicants regardless of race, color, national origin, interaction, religion, age, disability, veteran status, interactionual orientation, gender identity, or any other protected category.
We conduct background checks in accordance with company policies and federal and state guidelines. Job Location: Bolton, Massachusetts / Remote hybrid US Citizenship or permanent residency required
for proper measurement techniques. Assist in establishing Supplier requirements and flow downs for custom parts. Validates processes established during release phase of the New Product Introduction process. Assist with managing Quality approvals for part drawings created by the Engineering group.
Conducts Internal Quality Audits of the ISO 9001 systems and Headwall products and processes for deficiency identification and correction. Process owner of the Root Cause Corrective Action (RCCA) / Supplier Corrective Action process responsible for driving closure, maintaining records, and creating executive summaries. Assist with the returned materials (RMA) process, ensuring rapid closure of
RMAs and sound RCCA investigations. Ensures quality of delivered materials through final inspection, certificate of conformance, and other appropriate methodologies.
Provide support to Production for trouble shooting issues including those related to assembly, alignment, and qualification testing. Assist with collecting production data, analyzing outputs, and determining corrective courses of action to promote safety, quality, and efficiency. May perform other duties and responsibilities as assigned. Educational and Experience Qualifications: Bachelor's Degree in Industrial, Manufacturing, Mechanical or Optical Engineering or other related technical discipline. Six Sigma Green or Black
Belt certification strongly preferred. An outgoing detail-oriented person with superior communications skills, both verbal and written.
Strong computer desktop tool proficiency & other manufacturing software (MS-Word, Excel, etc. ) Routinely working in cross functional teams and influencing peers on project tasks. Proven experience effectively prioritizing workload to meet deadlines & work objectives. Effective quantitative ability, exceptional organizational (records) talent and analytical skills. Quality Engineer Responsibilities: Establishes and analyzes inspection and testing processes, mechanisms, and equipment for incoming material, and assists with creating executive summary reports.
Uses CMM, calipers, micrometers, gages, and other tools for mechanical measurements when required. Provide support and training to Quality Technicians for proper measurement techniques. Assist in establishing Supplier requirements and flow downs for custom parts. Validates processes established during release phase of the New Product Introduction process. Assist with managing Quality approvals for part drawings created by the Engineering group. Conducts Internal Quality Audits of the ISO 9001 systems and Headwall products and processes for deficiency identification and correction.
Process owner of the Root Cause Corrective Action (RCCA) / Supplier Corrective Action process responsible for driving closure, maintaining records, and creating executive summaries. Assist with the returned materials (RMA) process, ensuring rapid closure of RMAs and sound RCCA investigations. Ensures quality of delivered materials through final inspection, certificate of conformance, and other appropriate methodologies. Provide support to Production for trouble shooting issues including those related to assembly, alignment, and qualification testing. Assist with collecting production data, analyzing outputs, and determining corrective courses of action to promote safety, quality, and efficiency.
May perform other duties and responsibilities as assigned. Educational and Experience Qualifications: Bachelor's Degree in Industrial, Manufacturing, Mechanical or Optical Engineering or other related technical discipline. Six Sigma Green or Black Belt certification strongly preferred. An outgoing detail-oriented person with superior communications skills, both verbal and written. Strong computer desktop tool proficiency & other manufacturing software (MS-Word, Excel, etc.
) Routinely working in cross functional teams and influencing peers on project tasks. Proven experience effectively prioritizing workload to meet deadlines & work objectives. Effective quantitative ability, exceptional organizational (records) talent and analytical skills. Headwall Photonics Offers: Outstanding benefits package (including medical, dental, vision, life insurance) 401(k) plan with matching company contribution Generous holiday and paid time off schedules Other: Headwall is an Equal Opportunity Affirmative Action Employer and does not discriminate on the basis of race, religion, color, interaction, gender identity, interactionual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.
All employment is decided on the basis of qualifications, merit, and business need. We are an official Affirmative Action Program employer. Headwall encourages any United States citizen and others who are authorized to work in the United States to apply for these positions. Due to export restrictions, the candidate must be a US Citizen or Permanent Resident. No agencies, please
Our Purpose is to make people’s 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 Global Principal Quality Engineer (QMS transformation) is responsible for the creation and delivery of a comprehensive Global CAPA training program across the Olympus network, building competencies, CAPA training tools , designing training programs, e- learnings and coaching CAPA hours coaching channels throughout the Americas, EMEA, Japan, China, and APAC region to deliver strong understanding and applicability of Quality Management,
CAPA and Non-conformance process steps, Analysis of complex data, risk backssment tools, basic problem solving, root cause analysis, Human Error Analysis for prevention to ensure patient safety and company compliance Job Duties Creating engaging learning activities and compelling QMS course content through seeking inputs from SME and identifying target audience needs.
Applying tested instructional design theories, practice, and methods to deliver effective training programs. Create supporting material / media (audio, Computer based training modules, storyboards, video, simulations, role plays, games, interactive quizzes etc). Performs research and designing situation-appropriate learning
content for virtual or in class and measuring the results of training effectiveness and skill enhancement that is visualized in a Competency Model Score Card for global Engineers in Problem Solving, Green belt and Black belt development.
Supports LMS relevant information for timely reports and pushing learning items in learning catalogue for global attendance. Manages online learning communities and LMS content to effectively convey technical information to non-technical, first-time user or advanced user in the CAPA community of practice on Problem Solving, Technical writing and CAPA tools. Support and participate in internal and external Quality Audits (including notified bodies and health authorities) and ensure related CAPA activities are completed in a compliant and timely manner.
Collaborates with Subject Matter Experts on the learning needs and strategies across Olympus sites. Ability to lead indirect resources to develop training team network across Olympus. Collaborates with Olympus business partners to align training needs and system tool usage to facilitate types of training and tracking. Maintains training records directly or indirectly through Olympus locations. Collaborates with global CAPA community to understand future training needs and delivers solutions to enhance CAPA competency excellence and driving value to the business.
All Other Essential Duties as assigned by Management. Job Qualifications Required: BA/BS medical, engineering, scientific discipline Black Belt / Green Belt, Continuous improvement techniques and/or demonstrated problem solving and root cause techniques. Minimum of 8 years’ professional experience in a medical device manufacturer with demonstrated results in transformational Leadership inclusive of effective CAPA process & QMS to International Regulations and standards. Minimum of 5 years’ experience as Learning and Development Manager, Training Manager or similar, preferably to global users.
Proven experience in the delivery of training with excellent presentation public speaking and facilitation skills. Demonstrated experience in collaboration driving strong governance of a process and driving targeted improvements in performance. Demonstrated experience leading global change initiatives and integrations for multi-site and multi-product businesses through collaboration with the business and effectively interact with and influence teams and managers. Demonstrated experience in developing and leading skill enhancement of teams on strong problem solving, technical writing and statistical techniques.
Competent understanding of International medical device regulations specific expertise in; Regulatory Inspections, CAPA policy development & implementation, Mentoring and Coaching of teams, Strong analytics driving proactive solutions and demonstrated enhancements on CAPA principles. Competent understanding of International medical device regulations specific expertise in ISO 13485, 21 CFR Part 820, ISO 14971, SOR 98-282 CMDR (Canada), J-PAL (Japanese), European Medical Devices Directive.
Up to 25% international travel Availability to take evening and early morning teleconferences and training Proficiency in English and additional Languages preferred e. g. Japanese / German Preferred: Thorough knowledge of adult learning training and applying development principles and techniques for success. Knowledge of the application of Learning Management Systems or tools. Knowledge and experience with current and emerging Learning Technologies preferred. Demonstrated leadership in managing Regulatory Inspections & Notified Body audits. Excellent communication, project management, and budgeting skills.
Strong capability to influence at multiple levels within the organization on CAPA policy development & implementation, Mentoring and Coaching of teams. Strong interpersonal, analytical and project management in driving change. Competent with Microsoft Office 365 Suite, Visio, Adobe, Docu Sign, Agile and Windows platforms. 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.
The anticipated base pay range for this full-time position working at this location is $100,022.00 - $140,032.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications. 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) Massachusetts (US-MA) Southborough Quality & Regulatory Affairs (QA/RA)
