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$89k–$149k/yr
Full-time
bachelor degree, professional certificate
Posted 6h ago
~40 hrs/week
Responsibilities
Lead the development and standardization of inspection plans, work instructions, and acceptance criteria to ensure product quality and compliance. Partner with engineering and operations to translate complex requirements into practical documentation aligned with FDA and ISO standards.
Requirements
Requires a Bachelor's degree in Engineering and 4+ years of experience in quality or manufacturing engineering within a regulated industry. Proficiency in developing technical documentation and knowledge of quality inspection methods are essential.
Full job description
Work Flexibility: Onsite
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).
USN: $89,300 - $148,800 USD Annual
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer 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. More information is available at stryker.com and careers.stryker.com.
Facts:
● 2024 Sales: $22.6 billion
● Industry: Medical Instruments & Supplies
● Employees: 53,000 worldwide
● 44+ Manufacturing and R&D Locations Worldwide
● $1.5 billion spent on research and development in 2024
● ~14,200 patents owned globally in 2024
● Products sold in ~75 countries
● Fortune 500 Company
● 9 consecutive years as one a World's Best Workplace
Stryker’s social media community guidelines: https://www.stryker.com/content/m/legal/social-media-community-guidelines/en/index.html
Notice Regarding Employee Conduct on Facebook/LinkedIn
Meta/LinkedIn does not permit employers to verify or validate “employees” in the (META: “Works at” LinkedIn: “Experience”) section of users’ profiles. Please be aware that the views expressed by individuals on their personal accounts and do not necessarily represent the views of our company. If you encounter any issues with a person claiming to be our employee, we recommend using the “Report Profile” feature. If you’d like to report concerns to our Ethics Hotline, you may do so at: https://app.convercent.com/en-us/LandingPage/b6bb4e84-9fcb-ea11-a974-000d3ab9f296
Offices: 2825 Airview Boulevard, Kalamazoo, MI 49002, US · 600 Hope Pkwy SE, Leesburg, VA 21075, US · 571 Silveron Blvd, Flower Mound, TX, US · 325 Corporate Dr, Mahwah, NJ 07430, US · 4870 2100 S, Suite B, Salt Lake City, UT 84120, US
Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer 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. More information is available at stryker.com and careers.stryker.com.
Facts:
● 2024 Sales: $22.6 billion
● Industry: Medical Instruments & Supplies
● Employees: 53,000 worldwide
● 44+ Manufacturing and R&D Locations Worldwide
● $1.5 billion spent on research and development in 2024
● ~14,200 patents owned globally in 2024
● Products sold in ~75 countries
● Fortune 500 Company
● 9 consecutive years as one a World's Best Workplace
Stryker’s social media community guidelines: https://www.stryker.com/content/m/legal/social-media-community-guidelines/en/index.html
Notice Regarding Employee Conduct on Facebook/LinkedIn
Meta/LinkedIn does not permit employers to verify or validate “employees” in the (META: “Works at” LinkedIn: “Experience”) section of users’ profiles. Please be aware that the views expressed by individuals on their personal accounts and do not necessarily represent the views of our company. If you encounter any issues with a person claiming to be our employee, we recommend using the “Report Profile” feature. If you’d like to report concerns to our Ethics Hotline, you may do so at: https://app.convercent.com/en-us/LandingPage/b6bb4e84-9fcb-ea11-a974-000d3ab9f296
Offices: 2825 Airview Boulevard, Kalamazoo, MI 49002, US · 600 Hope Pkwy SE, Leesburg, VA 21075, US · 571 Silveron Blvd, Flower Mound, TX, US · 325 Corporate Dr, Mahwah, NJ 07430, US · 4870 2100 S, Suite B, Salt Lake City, UT 84120, US