US citizens and Greencard holders OVERVIEW: Be a part of the Quality team at our Healthcare Optics Research Laboratory and drive Quality for the development of unique software based biomedical devices in collaboration with world leading medical institutions.
We are seeking an experienced Medical Device Senior Software Quality Engineer (Sr Engineer, Software Quality Assurance) who can lead software design assurance and risk management activities and provide quality support of software development lifecycle processes and drive compliance. RESPONSIBILITIES: Ensure that software deliverables including software requirement specifications, software development plans, software architecture documents,
and software verification and validation plans are compliant to software development lifecycle process procedures Act as a member of Issue Review Team meetings to ensure that software bugs are evaluated and addressed appropriately Provide guidance on the selection of statistical analyses and sample size for design verification and validation and other qualification and acceptance testing Support the successful transfer of products to manufacturing by ensuring the adequacy of process validation, design transfer plans, quality plans and supplier documentation May plan and execute internal audits against applicable quality system standards, regulations and internal procedures.
QUALIFICATIONS:
Education: BS or higher degree in engineering, or similar Experience: 5 years minimum experience with a minimum of 3 years of Medical Device experience and a minimum of 3 years of Quality experience or design control experience, including experience in leading design control and risk management activities In-depth understanding of medical device design control and risk management Working knowledge of the requirements of FDA QSRs, ISO 13485, IEC 62304, IEC 60601 and ISO 14971 Experience with JIRA/JAMA software tools and their implementation is a plus Certification as an internal lead auditor for QSRs and/or ISO 13485 is a plus Skills: Proficient in Microsoft Office.
Experience in Minitab, JMP or similar statistical package HYBRID: This position offers a hybrid work schedule requiring you to be in the office 2 days a week and an option to work from home 3 day out of the week (unless a specific business need arises requiring in office attendance on other days). Note that work schedules and office reporting requirements may change from time to time based on business needs.
effective Regional oversight of the Quality Management System (QMS) in your local region to meet both regulatory and customer expectations. This includes harmonizing the quality standards and simplifying processes while driving both compliance and efficiency.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Performs Scientific Operational Excellence (SOE)n quality oversight on Pre-Clinical Research and Technical non-GMP R&D activities at the R&D site and creates partnership to implement and maintain fit-for-purpose quality standards. Responsible for ensuring that the activities conducted in
the R&D environment are performed in accordance with SOE, GLP, local, corporate and relevant international regulations and guidelines. Responsible for supporting inspection readiness as needed for the R&D functions.
Ensures stakeholder management with business with regards to the implementation of the SOE standards and represent SOE Quality at relevant R&D global initiatives/projects. Alone or in partnership designs and executes initiatives to improve efficiency, partnership and fit-for-purpose quality assurance and quality culture at the R&D site. Role Responsibility : Represent SOE Quality at the relevant functional and quality governance bodies. Represent SOE Quality at R&D global
initiatives level (e. g R&D QMS)Leads alone or in partnership design and implementation of SOE quality initiatives.
Operational Quality oversight on non-GMP scientific laboratories operations - input to risk management and management monitoring Quality oversight on R&D projects according to fit-for-purpose quality standards Proactive, risk proportioned quality input to R&D non-GMP processes and systems including quality review and approval of relevant written standards. Quality oversight on non-clinical GLP studies including immunogenicity phase. Quality Oversight on SOE Equipment and Computerized Systems Management SOE (non-GMP) Unplanned event/ CAPAs Management as compliance Authority Local and global Q4R&D Quality Projects support e.
g SOE, R&D QMS implementation Prepare and support the R&D functions for the audits performed by GSK (L2/L3 audit) and/or by external Health Authorities (L4 Audit) as applicable. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in shop, Science, or an engineering discipline, Chemistry, biology, bioengineering or shop or equivalent. Min. 2 years in the medical business in vaccines covering various areas: Technical research and development, preclinical, manufacturing.
2+ years of Manufacturing/Quality experience in the medical industry.2+ years' Experience with the application of Quality Systems in manufacturing, warehousing and distribution. Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's Degree is preferred. Ability to work independently and prioritize workload. Excellent oral and written communication skills. Strong interpersonal skills with an ability to enable and drive change. Problem identification and solving skills. Experience of working with multi-functional teams. Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. #LIGSK Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive.
Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at -xyz X (US Toll Free) or xyz X (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, interaction, pregnancy, marital status, interactionual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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