Principal Quality Engineer (CAPA) at Stryker

Irvine, California, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor's degree in engineering discipline required
Minimum of 8 years of related work experience with a strong understanding of corrective and preventive actions
Experience in medical devices or related industries
Strong knowledge of CAPA as it relates to Quality Management Systems, internal and external audits, product design controls, and risk management
Candidates must be within commutable distance of Irvine, CA
Willingness to travel 10%

Responsibilities

As the Inari Divisional Process Owner (DPO) of the CAPA subsystem, manage and maintain open CAPAs in the electronic TrackWise system
Provide expertise, training, and guidance in performing root cause analysis using appropriate investigation techniques
Conduct risk assessments to determine the impact of systemic non-conformities on QMS, product, and/or process
Develop detailed corrective and preventive action plans to address root cause(s) of existing and potential nonconformities
Lead efforts with cross-functional partners to execute action plan(s), ensuring that corrective and preventive actions do not adversely affect the finished product, patient safety, or regulatory compliance
Determine methodology for evaluating the effectiveness of corrective or preventive actions using appropriate statistical techniques
Perform data trending and analysis of CAPA metrics and present findings to cross-functional leadership
Ensure that all activities are performed and documented per company policies and procedures intended to assure product safety and effectiveness
Initiate, lead, and execute quality system improvement projects with substantial impact
Demonstrate appropriate risk-based decision making and prioritize key activities to maintain product conformity and QMS compliance
Support internal and external QMS audits as Subject Matter Expert for corrective and preventive actions within the product lifecycle and QMS
Lead the Inari Division CAPA program to ensure corrective and preventive actions are addressed in conformity with applicable global regulatory requirements and standards

Skills

CAPA

TrackWise

Root Cause Analysis

Risk Assessment

Statistical Techniques

Data Trending

QMS

Regulatory Compliance

Quality Audits

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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