{"id":2038463,"url":"https://alion.io/job/getinge-principal-engineer-quality","title":"Principal Engineer, Quality","company":{"id":719311,"name":"Getinge","domain":"getinge.com","url":"https://alion.io/company/getinge-2","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":{"grade":"A","score":100,"open_postings":5,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":23,"computed_at":"2026-10-10T05:45:15Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Merrimack, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":105000,"max_usd":210000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1343},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false},{"name":"Supervision","optional":false}],"status":"live","first_seen_at":"2026-10-07T17:01:46Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-10-10T23:20:57Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"With a passion for life\nJoin our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.\nAre you looking for an inspiring career? You just found it.\n\nJob Overview\nProvide Principal Quality Assurance level support and oversight to Corrective and Preventive Action (CAPA) activities and other activities within the Quality Compliance department. Mentor cross functional teams and other Quality Assurance Engineers. Facilitate activities to ensure effective and timely CAPAs. Drive continuous improvement activities.\nJob Responsibilities and Essential Duties\nCAPA (85%)\nAs a CAPA Coordinator, provide principal level expertise support and oversight to CAPA activities to ensure effective and timely CAPAs.\nGuide cross-functional teams through the CAPA request/CAPA process.\nLead and mentor cross-functional teams and facilitate activities.\nProvide project manager support to ensure CAPA activities and timelines are agreed upon, communicated, managed, and met.\nEnsure CAPA Request and CAPA activities are performed per procedures and regulations.\nDrive problem definition and scoping of CAPAs to assure that the CAPAs appropriately address underlying issues.\nLead and/or facilitate investigations and root cause analyses.\nGuide teams in documenting Effectiveness Check criteria.\nPerform CAPA Verification of Implementation and Effectiveness Check activities.\nProcess CAPA documentation within the electronic systems.\nServe as a facilitator and/or delegate for the CAPA Review Board as needed.\nCommunicate reminders and CAPA actions needed to personnel at all levels within the organization.\nDrive continuous improvement activities within the CAPA process.\nUpdate procedures and other documentation as needed to ensure continued compliance with regulations.\nDevelop and perform CAPA System training.\nMentor junior level engineers.\nQuality Compliance (10%)\nExecute tasks and projects that impact the Quality Management System (QMS) as required.\nPerform analysis on a new or revised standard and execute deliverables to support continuous compliance to applicable current standards and regulations.\nPerform Verification of Implementation (VOI) and Effectivity (VOE) of corrective actions.\nImprove and maintain the QMS in line with ISO 13485, Medical Device Regulation (EU-MDR), MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA) and regulatory requirements applicable to the Quality Management System Regulation (QMSR).\nOther (5%)\nAssist in meeting departmental goals and special projects as assigned.\nSupport external audits in various roles as assigned: scribe, backroom technical support and file preparation.\nPrepare documentation needed to fulfill requests from customers (internal and external).\nPerform other duties, as assigned.\nMinimum Requirements\nBachelor's Degree or Master's Degree in Engineering or Science, or equivalent work experience.\nMinimum 8 years' related experience working in medical device industry or other highly regulated industry, or equivalent.\nRequired Knowledge, Skills and Abilities\nExpertise in CAPA (Corrective & Preventive Action) systems and root cause analysis.\nDemonstrated ability to lead, motivate, and provide guidance to cross functional project teams to resolve quality-related issues in a timely and effective manner.\nExcellent problem-solving skills combined with technical understanding and knowledge of products.\nStrong organizational, project management, and leadership skills.\nAbility to prioritize and manage key deliverables in a fast-paced environment.\nMust be able to handle multiple responsibilities concurrently.\nExcellent verbal and written communication skills.\nHigh level of attention to detail and accuracy.\nStrong understanding of Quality System processes, ISO 13485, ISO 14971, and FDA requirements, including: NCR, supplier controls, process controls, design controls, verification and validation, risk management systems, and other quality practices.\nStrong computer skills, including MS Office applications (Word/Excel/Power Point/Outlook/Teams) and statistical software are required. Ability to analyze data and interpret results.\nSupervision/Management OfOthers:\nNot applicable.\nInternal and External Contacts/Relationships\nInteraction with all levels of personnel from various functions\nInteraction with cross-functional teams/departments\nInteraction with representatives from regulatory agencies and bodies\nEnvironmental/Safety/Physical Work Conditions\nEnsures environmental consciousness and safe practices are exhibited in decisions.\nUse of computer and telephone equipment and other related office accessories/devices to complete assignments.\nMay work extended hours during peak business cycles.\nHybrid office environment (works onsite and remotely).\nOccasional work in controlled environment.\n\nAbout us\nWith a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.\nBenefits at Getinge:\nAt Getinge, we offer a comprehensive benefits package, which includes:\nHealth, Dental, and Vision insurance benefits\n401k plan with company match\nPaid Time Off\nWellness initiative & Health Assistance Resources\nLife Insurance\nShort and Long Term Disability Benefits\nHealth and Dependent Care Flexible Spending Accounts\nCommuter Benefits\nParental and Caregiver Leave\nTuition Reimbursement\nGetinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.","description_format":"text","description_chars":6397,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["401k plan","Life insurance","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Hospitals & Health Systems","Cardiovascular Devices"],"lifecycle":[{"event":"open","at":"2026-10-07T17:01:46Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":2,"expected_fill_days":23,"reasons":["conf:0","velocity","win:early","comp:brand"],"computed_at":"2026-10-10T05:45:15Z"},"pay":null,"html_url":"https://alion.io/job/getinge-principal-engineer-quality","json_url":"https://alion.io/job/getinge-principal-engineer-quality.json","meta":{"generated_at":"2026-10-11T01:55:56Z","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","counted_by":"address","units_charged":1,"used_today":2923,"day_limit":5000,"remaining_today":2077,"minute_limit":60,"resets_at":"2026-10-12T00:00:00Z"}},"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":719311},"rest":"https://alion.io/mcp/rest/get_company?id=719311"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgetinge-principal-engineer-quality"},{"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%2Fgetinge-principal-engineer-quality"},{"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%2Fgetinge-principal-engineer-quality"},{"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/getinge-principal-engineer-quality\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgetinge-principal-engineer-quality"}]}