Post Market Quality Engineer (Hybrid)

Stryker; Redmond; Hybrid; AUD 114,000 - 181,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Wellbeing program

Job summary

Stryker in Redmond, WA seeks a Post Market Quality Engineer to drive post-market quality improvements. You will analyze complaints, lead CAPA/NC investigations, and work with R&D, Regulatory Affairs, Field Service and Sales to resolve issues.

Responsibilities include risk analyses, data trending, and ensuring compliance with QSRs and ISO standards. The role is hybrid/onsite, requiring strong analytical, communication, and cross-functional collaboration skills.

Qualifications

• Bachelor's degree in Engineering, Science, or related technical discipline.
• 0-2 years of professional experience.
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration skills.

Responsibilities

• Analyze and present post-market quality data including complaints, service reports, Q-metrics, and trending to identify continuous improvement opportunities.
• Investigate customer complaints and drive records to timely closure.
• Own and support Nonconformance (NC) and Corrective and Preventive Action (CAPA) investigations.
• Partner with customers and cross-functional teams including R&D, Regulatory Affairs, Field Service, and Sales to resolve product quality issues.
• Conduct and maintain risk analyses, document findings, and support Risk Management activities.
• Calculate failure and harm occurrence ratings using field performance data.
• Provide post-market quality input related to product safety, reliability, durability, and design performance.
• Ensure compliance with Quality System Regulations (QSRs), internal procedures, and applicable quality standards.
• Communicate product quality insights and trends to internal and external stakeholders.

Skills

Analytical skills

Problem solving

Communication

Education

Bachelor's degree in Engineering/Science

Job description

As a Post Market Quality Engineer, you will be responsible for continuous product and process quality improvements. You will conduct investigations into Customer Complaints, identify emerging trends, dictate action plans, and eventually own NC/CAPAs. You will support root cause activities and identify potential failure modes, risks, and resolve customer issues appropriately.

This role is Hybrid/Onsite in Redmond, Washington.

What You Will Do

• Analyze and present post-market quality data including complaints, service reports, Q-metrics, and trending to identify continuous improvement opportunities.
• Investigate customer complaints and drive records to timely closure.
• Own and support Nonconformance (NC) and Corrective and Preventive Action (CAPA) investigations.
• Partner with customers and cross-functional teams including R&D, Regulatory Affairs, Field Service, and Sales to resolve product quality issues.
• Conduct and maintain risk analyses, document findings, and support Risk Management activities.
• Calculate failure and harm occurrence ratings using field performance data.
• Provide post-market quality input related to product safety, reliability, durability, and design performance.
• Ensure compliance with Quality System Regulations (QSRs), internal procedures, and applicable quality standards.
• Communicate product quality insights and trends to internal and external stakeholders.

What You Need

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• 0 - 2 years of professional experience.
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration skills.
• Ability to manage multiple priorities and work effectively in a fast-paced environment.
• Demonstrated ability to learn quickly, navigate complexity, and drive results.

Preferred

• Experience working in a regulated industry such as Medical Device, Pharmaceuticals, Aerospace, or Manufacturing.
• Knowledge of complaint handling, post-market surveillance, CAPA, and nonconformance processes.
• Experience with failure investigation methodologies including Root Cause Analysis, 8D, or similar problem-solving tools.
• Familiarity with statistical analysis techniques and data trending.
• Knowledge of ISO 13485, ISO 14971, and FDA Quality System Regulations.
• Experience developing and implementing design controls and process controls.
• Experience supporting risk management and product quality improvement initiatives.

United States of America Pay Ranges:

• US15: $79,900 - $127,500 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

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.