Work Flexibility: Onsite
What you will do-
This position plays a critical role in ensuring that products meet the highest quality and regulatory standards. The individual will be responsible for defining and maintaining quality processes overseeing compliance with FDA and ISO requirements and leading a team of quality professionals to ensure that operations suppliers and products align with company standards and external regulations.
Key Responsibilities:
- Ensure full compliance with FDA ISO13485 and other applicable regulatory and quality standards across operations and suppliers.
- Define approve and implement inspection testing and evaluation procedures to maintain product accuracy precision and reliability.
- Lead and participate in internal and external audits including preparing documentation managing corrective actions and communicating results.
- Oversee complaint management failure analysis and nonconformance investigations ensuring proper documentation and corrective actions.
- Supervise coach and develop a team of Quality Engineers Technicians Supervisors and Coordinators setting departmental goals and monitoring performance.
- Provide training on Quality Assurance and Regulatory Affairs topics to ensure organizational knowledge and compliance.
- Maintain and review product controls acceptance activities and environmental health and safety management practices to drive continuous improvement.
- Generate review and communicate detailed proposals guidelines and procedures to support decision-making across departments.
What you need-
Required:
- B.S. in engineering engineering management or related discipline.
- Advanced English skills.
- Minimum of 3 years in Quality Assurance or related functional area.
- Minimum of 2 years as a supervisor of QA/RA function or equivalent experience.
- Minimum of 1 year of experience as people manager.
- Previous experience in the regulated manufacturing sector.
Desired:
- ISO Lead Auditor training; Certified Quality Engineer (ASQ).
- Previous Experience in the Medical Devices sector.
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 contractors legal duty to furnish information.
Required Experience:
Manager