Quality Engineer I

Job summary

Supports quality activities throughout product design, development, change control, and the product lifecycle, ensuring compliance with applicable regulations and standards. Maintains design and risk management documentation, supports verification and validation, audits, regulatory submissions, investigations, CAPA, quality improvement, and design transfers.

Job details

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. As 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. What You Can Expect Veille 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. Ce poste est basé sur site trois jours par semaine; toutefois, une présence accrue sur site peut être requise durant les périodes d’audit. Ensures 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. This position is on-site three days a week; however, increased on-site presence may be required during audit periods. How You'll Create Impact Travaille au sein d’une équipe en réalisant des activités qualité dans le cadre des processus de conception, de développement et de contrôle des changements. Assure la conformité aux réglementations mondiales et aux normes reconnues (p. ex., FDA 21 CFR Part 820, ISO 13485, ISO 14971, RDM de l’UE). Révise, tient à jour et approuve les dossiers d’historique de conception (DHF) et les dossiers de gestion des risques (RMF). Identifie et atténue les risques liés à la conception à l’aide de l’AMDEC (FMEA) et d’autres outils. Soutient les activités de vérification et de validation de la conception. Soutient les processus de conception et de contrôle des changements. Collabore avec les équipes de conception afin d’intégrer les normes de qualité. Rédige, révise et approuve la documentation dans le cadre de ses responsabilités en qualité. Définit et contrôle les caractéristiques critiques pour la qualité (CTQ). Participe aux soumissions réglementaires et aux audits. Analyse les données qualité afin d’identifier les tendances et les occasions d’amélioration. Soutient les initiatives d’amélioration de la qualité. Soutient les enquêtes sur les causes fondamentales et les activités CAPA. Soutient les transferts de conception et les transferts d’approvisionnement en collaboration avec les équipes Qualité fournisseurs. Soutient les enquêtes liées aux plaintes clients. Works as part of a team, completing Quality tasks in the design and development, and change control processes. Ensure compliance with global regulations and recognized standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR). Review, maintain and approve Design History Files (DHF) and Risk Management Files (RMF). Identify and mitigate design risks using FMEA and other tools. Support design verification and validation activities. Supports design and change control processes. Collaborate with design teams to embed quality standards. Author, review and approve documentation in Quality capacity. Define and control Critical to Quality (CTQ) characteristics. Assist with regulatory submissions and audits. Analyze quality data to identify trends and improvement areas. Support quality improvement initiatives. Support root cause investigations and CAPA activities. Supports design transfer and sourcing transfers with Supplier Quality counterparts. Supports customer complaints investigations. What Makes You Stand Out Expérience en contrôles de conception ainsi qu’en vérification et validation (conception, processus et logiciels). Connaissance pratique de la FDA 21 CFR 820.30, de l’ISO 13485 et du RDM de l’Union européenne. Compréhension de la gestion des risques (ISO 14971, AMDEC/FMEA et outils statistiques). Capacité à planifier et à exécuter des activités de V&V, y compris des études sur les facteurs humains et l’utilisabilité. Maîtrise de l’analyse statistique des données. Excellentes aptitudes à communiquer dans un environnement multidisciplinaire. Excellentes compétences en rédaction technique. Compétences en systèmes informatiques (atouts). Windchill Codebeamer Jira Microsoft Office Minitab Experience in design controls, verification, validation (design, process and software). Working knowledge of FDA 21 CFR 820.30, ISO 13485, and EU MDR. Understanding of risk management (ISO 14971, FMEA, statistical tools). Capable in V&V planning and execution including human factors usability studies. Proficient in statistical data analysis. Effective cross-functional communicator. Excellent technical writing skills. IT System Skills (Preferred Skills) Windchill Codebeamer Jira Microsoft Office Minitab Your Background Baccalauréat en génie ou dans un domaine connexe. Solide compréhension des principes d’ingénierie. Ceinture jaune ou ceinture verte Six Sigma, un atout. B.S. in Engineering or related field Solid foundation in engineering principles Six Sigma Yellow or Green Belt Preferred Travel Expectations Jusqu’à 20 % de déplacements. Up to 20% EOE/M/F/Vet/Disability

What you’ll do

Supports quality activities throughout product design, development, change control, and the product lifecycle, ensuring compliance with applicable regulations and standards. Maintains design and risk management documentation, supports verification and validation, audits, regulatory submissions, investigations, CAPA, quality improvement, and design transfers.

Requirements

Requires a bachelor's degree in engineering or a related field and a solid foundation in engineering principles. Desired qualifications include experience with design controls and verification and validation, knowledge of FDA, ISO 13485, ISO 14971, and EU MDR requirements, statistical analysis skills, strong technical writing and communication, and preferably a Six Sigma Yellow or Green Belt.

Benefits

• Employee Resource Groups
• Flexible Working Environment
• Competitive Total Rewards
• Wellness Incentives
• Recognition and Performance Awards

Listed skills

• Regulatory Compliance · Preferred
• Risk Management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Design Controls
• Design Verification and Validation
• Process Verification and Validation
• Software Verification and Validation
• Regulatory Compliance
• Risk Management
• FMEA
• Statistical Data Analysis
• Human Factors and Usability
• Technical Writing
• Cross-Functional Communication
• Root Cause Investigation
• CAPA
• Quality Data Analysis
• Design Transfer
• Change Control

Job areas

• Engineering
• Manufacturing
• Healthcare
• Science & Research