Senior Engineer, Quality Assurance at Stryker

Redmond, Washington, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree in science, engineering, or a related discipline
2+ years of experience in quality assurance or customer quality
Demonstrated experience with ISO 14971, ISO 13485, CFR 21 Part 820, and EUMDR
Experience conducting post-market quality assessments and product field actions
Candidates must reside within a commutable distance to Redmond, WA, and be able to work onsite several times per week (Hybrid)

Responsibilities

Lead product field action assessments (PFAA) from initiation through board approval, ensuring timely and thorough execution
Investigate customer complaints and non-conformances, determine root causes, and assess health risks to support regulatory compliance
Conduct health risk assessments (HRA) and document findings in Trackwise to support post-market surveillance
Author and manage non-conformance (NC) and corrective/preventive action (CAPA) records, collaborating with cross-functional teams to define deliverables and timelines
Provide statistical analysis and containment recommendations to support quality investigations and decision-making
Serve as a subject matter expert in risk management, product safety, and quality assurance processes, mentoring peers and supporting audits
Partner with regulatory teams to ensure accurate and timely reporting to competent authorities
Drive continuous improvement by strengthening interfaces between pre-market and post-market processes and promoting cohesive risk management strategies

Skills

Key technologies and capabilities for this role

ISO 14971ISO 1348521 CFR Part 820EU MDRTrackwiseCAPARoot Cause AnalysisHealth Risk AssessmentPost-Market SurveillanceStatistical AnalysisQuality AssuranceNon-Conformance Management

Questions & Answers

Common questions about this position

What is the salary range for the Senior Engineer, Quality Assurance position?

The salary range is $88,800 - $142,300 plus bonus eligible, generally eligible for short-term and long-term financial incentives, and benefits. Individual pay is based on skills, experience, and other relevant factors.

Is this a remote or hybrid role, and what are the location requirements?

This is a hybrid role where candidates must reside within a commutable distance to Redmond, WA, and be able to work onsite several times per week.

What are the required qualifications and skills for this position?

A Bachelor’s degree in science, engineering, or a related discipline is required, along with 2+ years of experience in quality assurance or customer quality, demonstrated experience with ISO 14971, ISO 13485, CFR 21 Part 820, and EUMDR, and experience conducting post-market quality assessments and product field actions.

What preferred qualifications can make a candidate stand out?

Preferred qualifications include a Master’s degree in a related field, Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE), Six Sigma Green Belt or Black Belt certification, and experience in a regulated industry such as Medical Device or Aerospace.

What is the expected travel requirement for this role?

The role involves up to 20% travel.

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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