Senior Quality Engineer

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

Benefits offered by this job

Health benefits

401(k) plan

Employee stock purchase plan

Wellbeing program

Job summary

Stryker in Irvine, CA seeks a Senior Quality Engineer to support QA, QC, and continuous improvement across manufacturing operations, products, and processes. You will partner with cross-functional teams and suppliers to resolve quality issues, drive CAPA and nonconformance actions, and ensure regulatory compliance.

The role requires a Bachelor's in science or engineering and at least 2 years in quality engineering, with strong skills in risk management, auditing, statistics, and MSA.

Qualifications

• Bachelor's degree in science, engineering or related field.
• Minimum of 2 years of quality engineering experience with risk mgmt, CAPA, auditing and statistics.
• Experience applying risk management and compliance assessments in a regulated environment.
• Proficiency using Microsoft Office to analyze data and create reports.
• Experience developing/test method validations, protocols, and MSA (Gage R&R).
• Experience managing supplier quality activities and supplier performance.

Responsibilities

• Partner with Operations, suppliers, and cross-functional teams to drive quality performance and improvements.
• Own and support nonconformances, CAPAs, MRB activities, and product disposition.
• Collaborate with suppliers on corrective actions, supplier changes, PPAP, and part certification.
• Monitor and report quality metrics; apply statistical methods to identify trends and drive changes.
• Support manufacturing-related complaints, field actions, and regulatory compliance.
• Develop and improve quality system documentation, inspection methods, and sampling plans.
• Support validations/qualifications, MSA, engineering changes, and manufacturing transfers.
• Participate in internal/external audits and provide quality SME guidance.

Skills

Quality engineering

Risk management

CAPA

Auditing

Statistical methods

Data analysis

Supplier quality

Education

Bachelor's degree in science or engineering

Tools

Gage R&R

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

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.