Quality Assurance Engineer - Hybrid - Michigan, Portage 3800 East Centre Ave

Work Flexibility: Hybrid

Quality Assurance Engineer – Hybrid

Stryker is hiring a Quality Assurance Engineer (Hybrid) located in Portage, Michigan.

As a Quality Engineer, you will primarily be responsible for continuous product and process quality improvements within the Emergency Care - Transport Business Unit. 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.

 

Workplace Flexibility: Candidate must reside within a commutable distance to Portage, Michigan but is expected to be onsite at the facility multiple times/week. The current team works onsite Monday, Tuesday & Wednesday and remotely Thursday and Friday but is subject to change at the discretion of the hiring manager.

 

Who we want:

·         Collaborative partners - People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

·         Dedicated achievers - People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

·         Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

 

What you will do:

·         Investigate sensitive customer complaints in a timely fashion and in accordance with global regulations

·         Communicate with customers, members of field service and sales organizations to gather information necessary to carry out investigations.

·         Gather, analyze, and present Post Market trending data (e.g. service reports, complaints, MDR/MIR, cost of poor quality) to identify opportunities for quality improvements

·         Lead and/or support NC and CAPA process by working with multifunctional teams (Ex: R&D, Operations, Manufacturing Engineering, Field Service, and Sales) to drive root cause and resolution. Document accurate and thorough investigation results within TrackWise.

·         Maintain risk management portfolio for product life, leading risk documentation updates as necessary. Conduct/update risk analysis within the risk management portfolio, as required.

·         Provide post-market input and feedback on safety, durability, craftsmanship, and reliability design input specifications for quality report, design reviews, risk analyses, and customer research.

·         Monitor compliance to Medical Quality Procedures, FDA, and other global health authority regulations.

·         Support internal and external audits (FDA, ISO, MDSAP, etc.)

 

What you need:

Required

·         Bachelor’s Degree in a Science or engineering related discipline

·         0+ years of work experience

Preferred

·         Knowledge and/or Experience working in a highly regulated environment – medical device is preferred.

·         Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).

·         Able to demonstrate strong communication, project management and ability to influence without authority. 

·         Able to demonstrate the ability to manage multiple tasks simultaneously.

·         Ability to represent Quality function with project teams.

Travel Percentage: 20%

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.