Quality Assurance Engineering Manager at Stryker

Redmond, Washington, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree in Engineering, Science, or a related field
8+ years of experience in quality assurance or customer quality
Demonstrated experience managing post-market quality processes and product field actions
Experience leading and developing teams
Demonstrated experience in Risk Management / Product Safety (ISO 14971)
Experience supporting internal and external audits and regulatory inspections
Candidates must reside within a commutable distance to Redmond, WA, and be able to work onsite several times per week (Hybrid)

Responsibilities

Establish a Quality Assurance Center of Excellence to drive consistency and excellence across post-market processes
Provide guidance for product field action assessments, non conformance and corrective/preventive actions, and ensure execution aligns with key performance indicators (KPIs) and regulatory expectations
Review and approve critical documentation including regulatory communications and customer-facing materials to ensure completeness and accuracy
Implement automated quality control methods to reduce errors and improve process efficiency
Partner with cross-functional teams to integrate pre-market and post-market risk management strategies
Serve as a subject matter expert during internal and external audits, including interactions with health authorities
Recruit, develop, and manage high-performing team members, fostering engagement and accountability
Define and monitor performance objectives and KPIs to ensure continuous improvement and operational excellence

Skills

Quality Assurance

Risk Management

Post-Market Surveillance

Product Field Actions

CAPA

Regulatory Compliance

Audits

Team Leadership

Process Improvement

KPI 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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