Staff Quality Engineer - Service

Overview

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

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).