Senior / Staff Quality Engineer, Product Transfer at Stryker

Freiburg, Baden-Wurttemberg, Germany

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DeviceIndustries

Requirements

Bachelor’s degree in Engineering, Sciences, or a related field
Minimum of 4 years’ experience in quality assurance and validation, ideally within the medical device or pharmaceutical industry
Strong knowledge of quality concepts, risk management tools (e.g., FMEA, PPAP), and regulatory standards (ISO 13485, FDA 21 CFR Part 820)
Proficiency in English & German
Preferred Qualifications
Experience in supplier quality and Quality Management Systems (QMS)
Hands-on experience with product transfers in regulated environments
Excellent communication, presentation, and project management skills, with strong attention to detail

Responsibilities

Support all production transfers globally (Supplier to Supplier, Supplier to Stryker, Stryker to Supplier, Stryker to Stryker)
Review and approve Validation and Qualification documentation
Act as the QA point of contact during the Scoping, Planning, and Execution of the supplier transfer
Provide quality guidance related to relevant regulations, corporate standards, and procedures (e.g., FMEA, MSA, Validations)
Identify potential quality risks during the transfer and propose effective solutions
Define QA strategies using a risk-based approach for FAI, inspection methods, and other key quality activities

Skills

FMEA

MSA

ISO 13485

FDA 21 CFR Part 820

PPAP

Validation

Qualification

Risk Management

Quality Assurance

Supplier Quality

QMS

Project Management

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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