Senior Quality Engineer, Medical Devices - CAPA & QA

Stryker Corporation; Irvine, Northern (CA, KY); Hybrid; Confidential; Full time

Job summary

Stryker Corporation is seeking a Senior Quality Engineer for its Peripheral Vascular division in Irvine, CA, onsite. You will partner with operations and suppliers to drive product/process quality, manage nonconformances, CAPAs, and MRB, and support supplier certifications.

You will analyze quality data, mentor teams, and ensure regulatory compliance across the quality system. The role requires a Bachelor's in a science/engineering field and at least 2 years in quality engineering, with

Qualifications

• Bachelors degree in science, engineering or related discipline.
• At least 2 years in quality engineering with knowledge of quality systems, risk management, CAPA, auditing, and statistics.
• Experience applying risk management and compliance risk assessments in regulated environments.
• Proficiency with MS Office for data analysis and reporting.
• Experience with test method validation, protocols, reports and MSA/Gage R&R.
• Experience leading supplier quality activities and supplier corrective actions.
• Preferred CQE/CRE and Six Sigma Green/Black belt; medical device knowledge a plus.
• Familiarity with ISO 13485, 21 CFR Part 820, GDP, GMP; regulatory inspections exposure.

Responsibilities

• Drive product and process quality, resolve issues, and promote continuous improvement.
• Own nonconformances, CAPAs, MRB, and product disposition with timely investigations and root cause analysis.
• Collaborate with suppliers on corrective actions, supplier changes, PPAP, and part certification.
• Monitor and report quality metrics using statistics and risk management.
• Support manufacturing-related complaints, field actions, and containment activities.
• Develop and update quality system docs, procedures, inspection methods, sampling plans, and HF practices.
• Assist in process, equipment, and supplier validations/qualifications, MSA, and manufacturing transfers.
• Participate in internal/external audits and provide quality SME support for regulatory compliance.

Skills

Quality engineering

CAPA

Risk management

Auditing

Statistical methods

MSA

Supplier quality

Gage R&R

PPAP

Microsoft Office

Education

Bachelors in science/engineering

Tools

Microsoft Office

Gage R&R

Job description

Stryker Corporation is seeking a Senior Quality Engineer for its Peripheral Vascular division in Irvine, CA, onsite. You will partner with operations and suppliers to drive product/process quality, manage nonconformances, CAPAs, and MRB, and support supplier certifications.

You will analyze quality data, mentor teams, and ensure regulatory compliance across the quality system. The role requires a Bachelor's in a science/engineering field and at least 2 years in quality engineering, with