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Stryker is hiring a Quality Assurance Engineer (Hybrid) , in Portage, MI to support Medical Acute Care! In this role, you will be supporting Post Market and responsible for continuous product and process quality improvements. You will conduct investigations into complaints/services, NCs, and CAPAs stemming from the products in the field, lead root cause activities and identify potential failure modes and risks to resolve customer issues.

Work Flexibility: Hybrid. This role requires proximity to our Stryker facility in Portage, MI, with at least three core onsite days (Monday-Wednesday). Additional onsite days may occasionally be required based on project needs.

What you will do:

Investigate and address sensitive customer complaints promptly, ensuring compliance with global regulations and thorough communication with customers, field service, and sales teams to gather necessary information, documenting results in the Complaint Handling System.

Collect, analyze, and present post-market data (such as service reports, complaints, and costs associated with poor quality) to identify and drive quality improvement opportunities within the Medical Division.

Lead and support Nonconformances (NC) and Corrective and Preventive Actions (CAPA) processes, including those that lead to field action assessments, by collaborating with cross-functional teams (RD, Operations, Manufacturing, etc.) to identify root causes and implement corrections and corrective action.

Facilitate product changes through sustainment, including Engineering Change Orders (ECO) and Process Change Orders (PCO), and develop rationales for verification or validation testing to resolve post-market issues.

Maintain and update risk management documentation throughout the product lifecycle, conducting risk assessments as needed to ensure current risk evaluation is complete and accurate.

Provide post-market feedback on safety, durability, craftsmanship, and reliability to inform design input specifications for quality reports, design reviews, and customer research.

Support ongoing quality assurance for products post-launch by monitoring market feedback and customer input to improve safety and effectiveness.

Monitor compliance with Medical Quality Procedures, FDA, and other global health regulations, and assist with internal and external audits (FDA, ISO, MDSAP, etc.).

What you need :

Required:

Bachelor’s degree in an Engineering related disciple is required with no prior work experience necessary.Preferred:

Preferred 1-2 years of engineering experience in a regulated industry (medical device, pharmaceutical, or FDA-regulated).

Basic knowledge of industry regulations (FDA QSR, ISO 13485, ISO 14971).

Proficiency in Microsoft Office (Outlook, Excel, Word).

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 ADD 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.

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.