Stryker Senior QA Engineer in Portage, Michigan
Help guide R&D through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products/processes.
Support process and product validation programs for new product development.
Involved in developing, modifying, and executing regulatory related company guidelines and procedures.
Provide input throughout the new product development process from a quality perspective.
Perform risk analysis and develop mitigation strategies
Collaborate with Design engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.
Educate R&D on the use of risk management tools, statistical methods, design and process control activities, and sound verification and validation test planning to help drive quality upfront in new product development.
Perform supplier development activities surrounding PPAP
Develop and create procedures for incoming, in-process, and final inspections for new product development
May conduct internal Quality system audits and be involved with CAPA projects.
May be involved in Quality related continuous improvement projects for the organization
May have involvement in training others on QA topics.
Work From Home: No
Travel Percentage: Up to 25%
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 one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com