Senior Quality Assurance Engineer at Stryker

Venlo, Limburg, Netherlands

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s degree (or equivalent) in Engineering, Quality or a related technical field
Minimum 3 years of experience in Quality Assurance within a regulated industry (medical devices preferred)
Strong understanding of ISO 13485, EU MDR, and FDA QSR requirements
Proven experience applying LEAN / Six Sigma or similar continuous improvement methodologies (Green Belt or higher)
Excellent analytical, problem-solving, and communication skills
Strong attention to detail, with a structured and proactive approach
Fluent in English (written and spoken). Any other language is a plus
Preferred
Experience working in a medical device distribution or manufacturing environment
Prior involvement in M&A integrations or multi-division quality initiatives
Familiarity with process automation tools or digital QMS platforms
Advanced knowledge of MS Office, especially Excel

Responsibilities

Own and maintain QMS processes, including Training, Document and Record Control
Support and lead activities related to non-conformances and Corrective and Preventive Actions
Develop, implement, and monitor QA processes, providing regular updates to stakeholders
Drive Continuous Improvement and LEAN initiatives in collaboration with internal and external partners
Support internal and external audits and ensure compliance with regulatory requirements
Lead QA efforts related to Value Added Services such as labeling, kitting, and other CDC operations
Collaborate with cross-functional teams and design divisions on new process setups, M&A integrations, and organizational change
Act as a quality ambassador, promoting risk management, process discipline, and a culture of excellence

Skills

ISO 13485

EU MDR

FDA QSR

Quality Management System

LEAN

Six Sigma

CAPA

Audits

Risk Management

Process Improvement

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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