Staff Quality Engineer Service
Kalamazoo, MI - USA
Job Summary
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.
As the Staff Quality Engineer - Service you will focus on developing and standardizing inspection documentation to support product quality compliance and operational efficiency. You will partner across engineering quality and operations to translate complex requirements into practical usable documentation.
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
Bachelors 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).
- USN: $89300 - $148800 USD Annual
Required Experience:
Staff IC
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more