Quality Assurance Engineer - AQE in Portage, MI at Stryker Corporation

Date Posted: 2/13/2020

Job Snapshot

Job Description

Who we want

Challengers.  People who seek out the hard projects and work to find just the right solutions.

Teammates.  Partners who listen to ideas, share thoughts and work together to move the business forward.

Customer-oriented achievers. People with an unparalleled work ethic and customer-focused attitude who bring value to their partnerships.

What you will do

Stryker is a brand that stands for quality, and we take pride in proactively building quality into our products. As an Advanced Quality Engineer, you will support the development of one or more products from concept generation through production, having the unique opportunity to realize the entire product lifecycle. Specifically, you will:

•Partner with marketing and design to understand user needs and translate those into engineering specifications that constitute the basis of the design
•Lead the development of a safety risk management strategy including implementation of risk controls
•Partner with suppliers and manufacturing to implement robust process controls
•Develop test protocols that represent real-world use scenarios to verify design inputs
•Lead component qualification and inspection development activities with suppliers
•Lead design validation activities including human factors engineering
•Monitor compliance to Stryker’s Quality Procedures and FDA Quality System Regulations (QSR’s) as well as all other product-specific standards/regulations and guide the team as necessary

What you need

•Bachelor of Science in Engineering
•GPA of 3.0 or higher
•Ability to think critically, solve complex problems, and work on large cross-functional and diverse teams
•Experience within medical device/manufacturing industry preferred
•Familiarity with ISO 13485 (medical device standard) and ISO 14971 (risk management standard) preferred
•Data analysis (statistical analysis, sampling plans, statistical process control, Minitab) experience is preferred
•Experience with development and implementation of design and process controls, geometric dimensioning & tolerancing, and industrial statistical techniques is preferred

Work From Home: Not available

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.

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