Ingénieur·e Qualité at Stryker

Décines-Charpieu, Auvergne-Rhone-Alpes, France

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Dispositifs médicaux, MédicalIndustries

Requirements

Diplôme Bac+3 minimum (Sciences, Qualité, Ingénierie ou domaine connexe)
Expérience confirmée (4 ans minimum) dans l’industrie, idéalement en dispositifs médicaux
Connaissances solides en réglementation (FDA, ISO 13485, GMP) et en outils qualité (NC-CAPA, résolution de problèmes, gestion des fournisseurs, change control)
Bonnes compétences en communication, gestion de projet et travail en équipe transversale
Force de propositions tournées vers l’amélioration continue et la gestion des risques
Maîtrise des outils informatiques et de la documentation qualité
Anglais professionnel requis – le français courant est indispensable

Responsibilities

Pilotez la performance qualité: Accompagnez les opérations industrielles et les fonctions transverses pour assurer la qualité des produits, process et changements
Gérez les non-conformités et CAPA: Prenez en charge les déviations internes et fournisseurs, menez les investigations et suivez la mise en œuvre d’actions correctives
Collaborez avec les fournisseurs: Échangez avec les partenaires externes sur les enjeux qualité, analysez les changements, évaluez les risques et réalisez les PPAP
Participez aux audits et inspections: Agissez en tant qu’expert·e qualité lors d’audits internes et externes, et garantissez la conformité aux exigences réglementaires (FDA, ISO 13485, GMP...)
Contribuez à l’amélioration continue: Proposez et pilotez des initiatives de réduction des défauts, d’optimisation des processus et d’amélioration de la satisfaction client
Analysez, mesurez, améliorez: Mettez en place et suivez des indicateurs qualité (KPI), réalisez des analyses de tendance et proposez des actions pertinentes
Apportez votre expertise technique: Soutenez les validations, MSA, qualifications, et assurez la robustesse des processus tout au long du cycle de vie produit
Faites rayonner la culture qualité: Accompagnez les équipes dans la compréhension des exigences, formez et encouragez les bonnes pratiques (facteurs humains, risques, conformité...)

Skills

Key technologies and capabilities for this role

ISO 13485FDAGMPNC-CAPAPPAPMSAKPICAPAauditsamélioration continuequalitédispositifs médicaux

Questions & Answers

Common questions about this position

What is the work arrangement for this position?

The position is onsite with full-time employment.

What education and experience are required?

A minimum Bac+3 diploma in Sciences, Quality, Engineering or related field is required, along with at least 4 years of confirmed experience in industry, ideally in medical devices.

What key skills and knowledge are needed for this role?

Solid knowledge of regulations (FDA, ISO 13485, GMP), quality tools (NC-CAPA, problem-solving, supplier management, change control), good communication, project management, and cross-functional teamwork skills are required. Professional English and fluent French are also necessary.

Is travel required for this job?

Yes, approximately 10% travel is required.

What makes a strong candidate for this Quality Engineer role?

Candidates with a collaborative approach, solid experience in regulated environments like medical devices, a proactive mindset for continuous improvement and risk management, and expertise in quality tools and regulations will stand out.

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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