{"id":1479674,"url":"https://alion.io/job/evergen-senior-quality-engineer","title":"Senior Quality Engineer","company":{"id":1929608,"name":"Evergen","domain":"evergenbio.com","url":"https://alion.io/company/evergenbio","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":{"grade":"B","score":75,"open_postings":8,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-03T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Eden Prairie, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":100000,"max":125000,"currency":"USD","period":"year","gross":null,"usd_annual":125000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false},{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-23T15:21:00Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-10-04T01:36:38Z","board_verified":true,"closed_at":null,"days_open":10,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":10},"description":"Location: Eden Prairie, MN\nAnnual CIP bonus opportunity of up to $10,000.00\nEvergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN; Eden Prairie and Glencoe, MN; Neunkirchen, Germany; Glasgow, UK; and Marton, New Zealand.\nWe are proud to be Great Place to Work® Certified in 2026, reflecting our commitment to creating an exceptional employee experience and workplace culture. Evergen currently has full-time career opportunities available across multiple locations.\nOur comprehensive benefits package includes:\nPaid Time Off (PTO)\n401(k) with up to a 6% company match\nHoliday pay\nMedical, dental, and vision insurance\nShort-term and long-term disability coverage\nPaid parental leave and much more!\nRead more about this change and Evergen’s commitment to advancing regenerative medicine here:https://www.linkedin.com/company/evergenbio\nRESPONSIBILITIES\nAct as quality lead for major design and manufacturing projects, ensuring robust risk management and compliance.\nOwn and optimize quality system processes (e.g., CAPA, supplier quality, complaint handling, statistical techniques).\nLead complex investigations and implement systemic corrective/preventive actions.\nProvide expertise in reliability engineering, process validation, and design for quality.\nRepresent the company as a quality expert during FDA inspections, notified body audits, and supplier audits.\nCollaborate with executive leadership to align quality strategies with business objectives.\nMentor and coach quality engineers across multiple sites or functions.\nREQUIREMENTS\nEducation\nBachelor’s or Master’s degree in engineering, life sciences, or related discipline.\nExperience\n6+ years of progressively responsible quality experience in the medical device industry.\nDeep knowledge of global regulatory standards (FDA QSR, ISO 13485, EU MDR, MDSAP).\nProven success leading cross-functional projects and influencing at senior levels.\nAdvanced statistical analysis, risk management (ISO 14971), and Six Sigma Black Belt preferred.\nTrack record of leading successful audits and remediation projects.\nCertification\nAATB or CTBS Certification, preferred \nLead Auditor Certification, preferred\nASQ - CQE, CBA, or CQA, preferred\nSkills\nExcellent verbal and written communication\nTechnical writing\nProblem solving methodologies\nMicrosoft Office Suite\nQuality Management System software\nInvestigations\nStatistical techniques\nTravel\nUp to 25% including international\nSAFETY\nPhysical Requirement\nMove or lift objects up to 25 pounds\nFrequent (>75%) stationary position (standing or sitting) while utilizing digital displays\nFrequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)\nWorking Environment\nOnsite: Office environment with assigned workstation\nRemote positions only: Home office environment with minimum distractions\nMore about Evergen:\nEvergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.\nEvergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:\nAccountable: We own our actions and decisions.\nAgile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth. \nGrowth Mindset: We embrace challenges as opportunities for continuous learning.\nCustomer-Centric: We prioritize customers at every touch point. \n Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated. \nAt Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.\nMontagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.\n#LI-Onsite","description_format":"text","description_chars":4874,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Continuous learning","Equity","Home office","Parental leave","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Advanced Materials"],"lifecycle":[{"event":"open","at":"2026-09-29T20:23:21Z"}],"visa":[],"liveness":{"score":77,"band":"hot","label":"Hiring now","p_open":0.9,"p_active":0.86,"p_room":1,"age_days":9,"expected_fill_days":40,"reasons":["conf:71","win:early"],"computed_at":"2026-10-03T05:45:00Z"},"pay":{"stated_usd_annual":125000,"is_top_pay":false},"html_url":"https://alion.io/job/evergen-senior-quality-engineer","json_url":"https://alion.io/job/evergen-senior-quality-engineer.json","meta":{"generated_at":"2026-10-04T02:47:41Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":4135,"day_limit":5000,"remaining_today":865,"minute_limit":60,"resets_at":"2026-10-05T00:00:00Z"}}}