Sr Engineer, Quality Assurance Engineering
Role summary
Stryker is seeking a Sr. Engineer, Quality Assurance Engineering to lead and advocate for quality initiatives, ensuring compliance with regulations and standards in a heavily regulated manufacturing environment. This role involves providing validation engineering support, overseeing quality processes like NCs and CAPAs, and mentoring teams in problem-solving. The engineer will also support change management, risk management activities, and quality acceptance tests. Key responsibilities include acting as a site owner for validation specialties and interfacing with auditors. A Bachelor's degree in engineering and a minimum of 2 years of experience in quality, engineering, or validation within a regulated environment are required.
Work Flexibility: Onsite
Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Supporting validation activities by providing guidance and expertise to authors of validation documentation and executors of validation protocols at the local site.
What You Will Do
- Provide quality and validation engineering support to ensure compliance with applicable regulations, standards, and internal procedures.
- Lead and advocate for quality initiatives focused on preventative measures, continuous improvement, and risk reduction across products and processes.
- Oversee, review, and approve Non-Conformances (NCs), CAPAs, and root-cause investigations, mentoring teams in structured problem-solving methodologies.
- Support and approve change management activities, ensuring effective risk evaluation and regulatory compliance.
- Provide subject-matter expertise for process, equipment, and computer system validation/qualification, including review and approval of validation documentation.
- Actively participate in the development and improvement of manufacturing processes for existing and new products.
- Support execution, analysis, and review of Quality Acceptance Tests (QATs) and First Article Inspections.
- Lead and contribute to risk management activities, applying tools such as FMEAs, FTAs, and other risk-based techniques.
- Serve as site owner for at least one validation specialty, acting as the primary technical resource and validation contact.
- Interface with internal and external auditors and regulatory bodies, providing clear and effective technical narratives within your area of expertise.
- Collaborate cross-functionally to ensure quality and validation considerations are effectively integrated into operational and project decisions.
What You Need
- Bachelor's degree in engineering
- Minimum 2 years of experience in quality, engineering, validation, or a heavily regulated environment.
Preferred
- Engineering degree in Mechanical, Electrical, Chemical, or Biomedical Engineering.
- 2+ years of experience in quality, engineering, validation, or regulated manufacturing environments.
- Experience supporting R&D, New Product Development (NPD), New Product Introduction (NPI), or Commercial Operations activities.
- Familiarity with ISO 13485, GMP, GDP, and medical device manufacturing processes.
- $89,400.00 - 148,900.00 USD Annual salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
Travel Percentage: 10%
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.
