{"id":2383417,"url":"https://alion.io/job/gsk-senior-device-quality-engineer-associate-director","title":"Senior Device Quality Engineer Associate Director","company":{"id":6649,"name":"GSK","domain":"gsk.com","url":"https://alion.io/company/gsk","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":82,"open_postings":42,"ghost_share":0,"stale_share":0.929,"repost_share":0,"time_to_fill_p50_days":17,"computed_at":"2026-10-24T06:02:35Z"}},"role":"Leadership","role_family":"Leadership","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Providence, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":197000,"max_usd":369000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2576},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"EU MDR","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Design of Experiments","optional":true}],"status":"live","first_seen_at":"2026-10-12T19:50:23Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-10-24T04:20:21Z","board_verified":true,"closed_at":null,"days_open":11,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":11},"description":"Business Introduction:\nWe manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bring our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.\nPosition Summary:\nYou will lead quality engineering activities for medical device products. You will work across design, manufacturing, and regulatory teams to ensure product safety, reliability, and compliance. We value clear communicators who solve problems with data and practical judgment. You will grow your career by influencing product quality and patient outcomes while working with talented, multidisciplinary teams aligned to our mission of uniting science, technology and talent to get ahead of disease together.\nKey Responsibilities:\nProvide quality oversight of device design control activities for new combination products from clinical design planning through first commercial product launch.\nSupport design transfer and manufacturing scale-up to ensure robust processes and device conformity.\nEnsure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices within combination products.\nProvide quality oversight of risk management files (ISO 14971) and Design and Development Files (ISO 13485).\nSupport and contribute to device development process and QMS improvements.\nLead investigations into quality events, using root cause analysis and corrective action plans.\nReview and approve quality documents, including protocols, test reports, and risk management files.\nMonitor product performance through post-market surveillance and drive continuous improvement.\nCollaborate with regulatory, supply chain, and manufacturing partners to support audits and inspections.\n\nBasic Qualifications:\nBachelor’s degree in biomedical, mechanical, electrical engineering, quality engineering, or related field.\nMinimum 5 years’ experience in medical device quality engineering or regulated manufacturing.\nWorking knowledge of quality systems and standards relevant to medical devices, such as ISO 13485 and FDA 21 CFR part 820.\nHands-on experience with root cause analysis and CAPA (corrective and preventive action) execution.\nAbility to read and review technical drawings, specifications, and test data. Strong communication skills and experience working cross-functionally with engineering and operations teams.\nPreferred Qualifications:\nAdvanced degree in engineering or quality-related discipline.\nExperience with risk management standards such as ISO 14971.\nFamiliarity with supplier quality management and supplier audits.\nProficiency with statistical tools, design of experiments (DOE), and process capability analysis.\nExperience supporting regulatory submissions or inspections.\nWork Arrangement:\nThis role is hybrid, with regular onsite collaboration in the United States and some remote flexibility. Travel may be required for supplier visits, audits, or cross-site collaboration.\n\nWhat we offer you:\nYou will join a team focused on meaningful, measurable impact for people who need better health outcomes. You will receive opportunities to develop technical skills, lead important projects, and grow your career. We support an inclusive environment where everyone can contribute and learn.\n\nReady to join us?\nIf this role excites you, we encourage you to apply. Tell us about your experience, what you care about, and how you want to grow. We look forward to hearing from you.\nSkills\nData Integrity, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Project Management, Quality Assurance (QA), Quality Management Systems (QMS), Risk Awareness, Technical WritingPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.\nWhy GSK?\nUniting science, technology and talent to get ahead of disease together.\nGSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.\nPeople and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.\nIf you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - \nGSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.\nImportant notice to Employment businesses/ Agencies\nGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.\nPlease note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/","description_format":"text","description_chars":7596,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Vaccines","Oncology Therapeutics","Infectious Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-12T19:50:23Z"}],"visa":[],"liveness":{"score":55,"band":"ok","label":"Likely open","p_open":1,"p_active":0.61,"p_room":0.9,"age_days":11,"expected_fill_days":17,"reasons":["conf:1","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-24T06:02:35Z"},"pay":null,"html_url":"https://alion.io/job/gsk-senior-device-quality-engineer-associate-director","json_url":"https://alion.io/job/gsk-senior-device-quality-engineer-associate-director.json","meta":{"generated_at":"2026-10-24T17:34:40Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":25579,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":6649},"rest":"https://alion.io/mcp/rest/get_company?id=6649"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgsk-senior-device-quality-engineer-associate-director"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fgsk-senior-device-quality-engineer-associate-director"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fgsk-senior-device-quality-engineer-associate-director"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/gsk-senior-device-quality-engineer-associate-director\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgsk-senior-device-quality-engineer-associate-director"}]}