Senior Quality Engineer

Stryker Group; Irvine (CA); On-site; USD 89,000 - 149,000; Full time

Job summary

Stryker in Irvine, CA seeks a Senior Quality Engineer to provide QA/QC support across manufacturing operations, products and processes within Peripheral Vascular. You will lead CAPAs, MRBs and supplier actions while partnering with cross-functional teams to drive improvements and ensure regulatory compliance.

The role focuses on risk-based quality systems, process validation, and continuous improvement to enhance product quality and customer satisfaction.

Qualifications

• Minimum of 2 years of quality engineering experience with knowledge of quality system principles.
• Experience applying risk management principles and conducting compliance risk assessments in a regulated environment.
• Proficiency with data analysis, reporting, and cross-functional collaboration.
• Experience developing and executing test method validations and measurement system analyses.

Responsibilities

• Partner with Operations, suppliers, and cross-functional teams to drive quality performance and continuous improvement.
• Own nonconformances, CAPAs, MRB activities, and product disposition with timely investigations and corrective actions.
• Collaborate with suppliers on quality concerns, supplier changes, PPAP, and supplier part certification.
• Monitor and report quality metrics using statistical methods and risk management.
• Support manufacturing-related complaints, field actions, and regulatory compliance activities.
• Develop and improve quality system documentation, procedures, and sampling plans.
• Support validations/qualifications, MSA, engineering changes, and manufacturing transfers.
• Participate in audits and provide QA expertise to regulatory requirements.

Skills

Quality engineering

Risk management

CAPA

Auditing

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Tools

Microsoft Office

Gage R&R

PPAP

Job description

Stryker is hiring a Senior Quality Engineer for our Peripheral Vascular division in Irvine, CA to provide Quality Engineering support for quality assurance, quality control, and continuous improvement activities across manufacturing operations, products, and processes. Partner closely with cross-functional teams and suppliers to resolve quality issues, drive corrective and preventive actions, and enhance overall quality performance. Lead and support initiatives that improve product quality, operational efficiency, and customer satisfaction while ensuring compliance with applicable regulatory requirements, industry standards, and quality system expectations.

What you will do

• Partner with Operations, suppliers, and cross-functional teams to drive product and process quality performance, resolve quality issues, and support continuous improvement initiatives.

• Own and support nonconformances (NCs), CAPAs, MRB activities, and product disposition, ensuring timely investigation, root cause analysis, corrective actions, and closure within quality systems.

• Collaborate with suppliers to address quality concerns, manage supplier corrective actions, evaluate supplier changes, perform PPAP activities, and support supplier part certification programs.

• Monitor, analyze, and report quality and process performance metrics, applying statistical methods, process controls, and risk management principles to identify trends and drive improvements.

• Support manufacturing-related complaints, field actions, commercial holds, and containment activities to ensure product quality and regulatory compliance.

• Develop, review, and improve quality system documentation, procedures, inspection methods, sampling plans, and Human Factors practices that enhance product and process effectiveness.

• Support process, equipment, and supplier validations/qualifications, measurement system analysis (MSA), engineering changes, supplier-initiated changes, and manufacturing transfer activities.

• Participate in internal and external audits and provide quality subject matter expertise to ensure compliance with applicable quality system and regulatory requirements.

What you need:

Required

• Bachelors degree in a science, engineering or related discipline

• Minimum of 2 years of quality engineering experience with demonstrated knowledge of quality system principles, including risk management, CAPA, auditing, and statistical methodologies.

• Experience applying risk management principles and conducting compliance risk assessments within a regulated environment.

• Demonstrated proficiency using Microsoft Office tools to analyze data, create reports, and support cross-functional business activities.

• Experience developing and executing test method validations, including authoring and revising protocols, reports, procedures, and/or work instructions, as well as conducting measurement system analyses (e.g., Gage R&R).

• Experience managing supplier quality activities, including supplier qualification, performance monitoring, and quality issue resolution.

Preferred

• CQE, or CRE and Six Sigma Green or Black belt preferred Or related

• Experience in the medical device industry with knowledge of U.S. and international medical device regulations, including familiarity with ISO 13485, 21 CFR Part 820, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).

• Experience with regulatory inspections and audits, including direct interaction with regulatory agencies such as FDA, TUV, MoH, etc.

• Experience developing, programming, and validating automated inspection programs, protocols, and recipes for manufacturing or quality inspection systems.

$89,400 - $148,900 USD Annual