{"id":4243898,"url":"https://alion.io/job/zimmer-biomet-quality-engineer-i-2","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":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Montreal, Canada"],"countries":["CA"],"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 Controls","optional":false},{"name":"Design History File","optional":false},{"name":"EU MDR","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Jira","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Minitab","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-11-05T00:00:00Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-13T12:29:14Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"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\nVeille à ce que les produits de Zimmer Biomet et les produits compatibles respectent les exigences réglementaires, de qualité et des clients tout au long du processus de conception et de développement ainsi que du cycle de vie des produits. Collabore avec des équipes multidisciplinaires et des partenaires externes afin d’atteindre les objectifs de qualité et d’affaires de Zimmer Biomet.\nCe poste est basé sur site trois jours par semaine; toutefois, une présence accrue sur site peut être requise durant les périodes d’audit.\nEnsures Zimmer Biomet and compatible products meet regulatory, quality, and customer requirements throughout the design and development process, and product lifecycle. Collaborates cross-functionally and with external partners to achieve Zimmer Biomet’s quality and business objectives.\nThis position is on-site three days a week; however, increased on-site presence may be required during audit periods.\nHow You'll Create Impact\nTravaille au sein d’une équipe en réalisant des activités qualité dans le cadre des processus de conception, de développement et de contrôle des changements.\nAssure la conformité aux réglementations mondiales et aux normes reconnues (p. ex., FDA 21 CFR Part 820, ISO 13485, ISO 14971, RDM de l’UE).\nRévise, tient à jour et approuve les dossiers d’historique de conception (DHF) et les dossiers de gestion des risques (RMF).\nIdentifie et atténue les risques liés à la conception à l’aide de l’AMDEC (FMEA) et d’autres outils.\nSoutient les activités de vérification et de validation de la conception.\nSoutient les processus de conception et de contrôle des changements.\nCollabore avec les équipes de conception afin d’intégrer les normes de qualité.\nRédige, révise et approuve la documentation dans le cadre de ses responsabilités en qualité.\nDéfinit et contrôle les caractéristiques critiques pour la qualité (CTQ).\nParticipe aux soumissions réglementaires et aux audits.\nAnalyse les données qualité afin d’identifier les tendances et les occasions d’amélioration.\nSoutient les initiatives d’amélioration de la qualité.\nSoutient les enquêtes sur les causes fondamentales et les activités CAPA.\nSoutient les transferts de conception et les transferts d’approvisionnement en collaboration avec les équipes Qualité fournisseurs.\nSoutient les enquêtes liées aux plaintes clients.\nWorks as part of a team, completing Quality tasks in the design and development, and change control processes. \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. \nAnalyze 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. \nWhat Makes You Stand Out\nExpérience en contrôles de conception ainsi qu’en vérification et validation (conception, processus et logiciels).\nConnaissance pratique de la FDA 21 CFR 820.30, de l’ISO 13485 et du RDM de l’Union européenne.\nCompréhension de la gestion des risques (ISO 14971, AMDEC/FMEA et outils statistiques).\nCapacité à planifier et à exécuter des activités de V&V, y compris des études sur les facteurs humains et l’utilisabilité.\nMaîtrise de l’analyse statistique des données.\nExcellentes aptitudes à communiquer dans un environnement multidisciplinaire.\nExcellentes compétences en rédaction technique.\nCompétences en systèmes informatiques (atouts).Windchill\nCodebeamer\nJira\nMicrosoft Office\nMinitab\n\nExperience in design controls, verification, validation (design, process and software). \nWorking knowledge of FDA 21 CFR 820.30, ISO 13485, and EU MDR. \nUnderstanding of risk management (ISO 14971, FMEA, statistical tools). \nCapable in V&V planning and execution including human factors usability studies. \nProficient in statistical data analysis. \nEffective cross-functional communicator. \nExcellent technical writing skills. \nIT System Skills (Preferred Skills) Windchill \nCodebeamer \nJira \nMicrosoft Office \nMinitab \n\nYour Background\nBaccalauréat en génie ou dans un domaine connexe.\nSolide compréhension des principes d’ingénierie.\nCeinture jaune ou ceinture verte Six Sigma, un atout.\nB.S. in Engineering or related field \nSolid foundation in engineering principles \nSix Sigma Yellow or Green Belt Preferred \nTravel Expectations\nJusqu’à 20 % de déplacements.\nUp to 20%\nEOE/M/F/Vet/Disability","description_format":"text","description_chars":5753,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":false},"security_clearance":false,"languages":[{"language":"French","level":"Advanced (C1)","optional":false}]},"benefits":["Flexible schedule"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Orthopedic & Spine 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