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Advanced Quality Engineer
4 months ago
Work Flexibility: HybridStryker is hiring an Advanced Quality Engineer (Hybrid) in Portage, MI to support our Medical Division In this role, you will have the unique opportunity to support the development of one or more products from concept generation through production, experiencing the entire product lifecycle.You will provide input to R&D designs from a quality perspective, work with a cross functional team to develop test strategies for product designs, and analyze the risk associated with these designs to recommend improvements to new and existing product design.Work Flexibility: Hybrid. This role requires reasonable proximity to our Portage, MI. You should be comfortable working 3-days onsite.Who we want:Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to design medical devices.What you will do:Work closely with the R&D team to ensure that product designs meet quality requirements such as safety, effectiveness; participate in customer preference testing and apply learnings towards usability.Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.Partner with suppliers and manufacturing to implement robust process controls.Participate in design reviews and lead risk management associated activities - tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.Lead design validation activities including human factors engineering (usability).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.Support product design and quality transfers to internal and/or external manufacturing facilities.What you need:Required Qualifications:Bachelor's degree in engineering is required. Preferred to be mechanical or biomedical.0+ required years of experience.Preferred Qualifications:Ability to think critically, solve complex problems, and work with and influence 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.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.
