Staff Quality Engineer - Service
Job Description
Stryker is hiring a Staff Quality Engineer - Service for our Instruments division. This is an onsite role based 5 days per week in Kalamazoo, MI.
What you will do
- Lead development and standardization of inspection plans, work instructions, and acceptance criteria across product lines.
- Evaluate current inspection processes and documentation to identify gaps, inconsistencies, and improvement opportunities.
- Translate engineering drawings, specifications, and regulatory requirements into clear and accurate inspection documentation.
- Collaborate with cross-functional teams to gather requirements and align documentation with operational needs.
- Facilitate document reviews, approvals, and implementation to ensure timely adoption and compliance.
- Ensure all documentation aligns with regulatory standards, including FDA requirements and ISO 13485.
- Develop templates and best practices to improve efficiency and consistency across inspection processes.
- Manage project timelines, deliverables, and stakeholder updates to ensure completion within defined schedules.
What you need
- Required:
- Bachelor’s degree in Engineering or a related technical discipline.
- 4+ years of experience in quality engineering, manufacturing engineering, or quality systems within a regulated industry.
- Experience developing technical documentation such as inspection plans, work instructions, or quality procedures.
- Knowledge of quality inspection methods, measurement systems, and quality control principles.
- PREFERRED:
- Experience in medical device development or manufacturing.
- Knowledge of FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices.
- Experience using document control systems or quality management systems.
- Professional certification (e.g., Certified Quality Engineer, Six Sigma Green Belt or higher).
Pay
$89,300 - $148,800 USD Annual
Benefits
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. Click here to learn more about: US Stryker employee benefits
About the Role
Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Qualifications
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.