{"id":4244336,"url":"https://alion.io/job/zimmer-biomet-quality-engineer-i-3","title":"Quality Engineer I","company":{"id":9247,"name":"Zimmer Biomet","domain":"zimmerbiomet.com","url":"https://alion.io/company/zimmer-biomet","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Phenom","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bengaluru, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design History File","optional":false},{"name":"EU MDR","optional":false},{"name":"FMEA","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-11-03T00:00:00Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-13T12:29:14Z","board_verified":true,"closed_at":null,"days_open":10,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":10},"description":"At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.\nAs a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.\nWhat You Can Expect\nJob Summary:\nThe Quality Engineer is an entry level position responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer Biomet to implement Zimmer Biomet Quality goals.\nWork Location: Bangalore\nWork Mode: Hybrid (3 Days in office)\nHow You'll Create Impact\nPrinciple Duties and Responsibilities:\nEnsure compliance with global regulations and recognized standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR).\nReview, maintain and approve Design History Files (DHF) and Risk Management Files (RMF).\nIdentify and mitigate design risks using FMEA and other tools.\nSupport design verification and validation activities.\nSupports design and change control processes.\nCollaborate with design teams to embed quality standards.\nAuthor, review and approve documentation in Quality capacity.\nDefine and control Critical to Quality (CTQ) characteristics.\nAssist with regulatory submissions and audits.\nAnalyse quality data to identify trends and improvement areas.\nSupport quality improvement initiatives.\nSupport root cause investigations and CAPA activities.\nSupports design transfer and sourcing transfers with Supplier Quality counterparts.\nSupports customer complaints investigations.\nManagement of product nonconformance, hold and field action records and activities.\nSupport audit, inspection, and regulatory submission readiness activities as needed.\nWhat Makes You Stand Out\nYour Background\nEducation/Experience Requirements\nBachelor’s degree with 1-3 year’s of related experience.\nFamiliarity with 21 CFR 820/ISO13485/IEC 62304 and other government/ISO standards preferred. \nExperience in regulated industries. \n Medical device experience preferred.\nStrong computer skills (MS Office Suite and Adobe). \nPhysical Requirements\nTravel 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