Manager, Quality Assurance (Onsite)

Work Flexibility: Onsite

Stryker is hiring a Manger Quality Assurance for our TMJ portfolio located in Ventura California.

This is an onsite position based in Strykers Ventura office five days per week.

As the Manager Quality Assurance you will lead quality assurance activities that support product quality process performance audit readiness and continuous improvement across site operations. Working closely with Operations Global Quality Regulatory Affairs and supplier partners you will help ensure quality systems remain effective compliant and aligned with business objectives.

What You Will Do

• Lead and develop a team of quality professionals establishing performance objectives development plans and quality-focused operating practices.

• Partner with manufacturing and operational teams to ensure products and processes consistently meet quality regulatory and company requirements.

• Oversee quality system activities including corrective and preventive actions change management product and process validation investigations and acceptance activities.

• Manage regulatory notified body customer and internal audits ensuring audit readiness and timely resolution of observations.

• Develop monitor and report quality metrics using trend analysis to identify improvement opportunities and support decision-making.

• Lead quality-related communications regarding product holds investigations and potential field actions with cross-functional stakeholders.

• Implement training programs that strengthen understanding of regulatory requirements quality system processes and compliance expectations.

• Support supplier quality activities continuous improvement initiatives acquisition integrations budgeting activities and strategic quality planning.

What You Need

Required

• Bachelors degree in Engineering Quality Life Sciences Manufacturing or a related technical discipline.

• Minimum 6 years of experience in a technical manufacturing quality or engineering role within a regulated industry.

• Minimum 3 years of experience leading teams projects or quality management activities.

• Experience working within a regulated manufacturing environment including compliance with FDA and/or international quality standards.

• Experience supporting quality systems audits investigations corrective actions and process improvement initiatives.

Preferred

• Minimum 3 years of quality management experience in the medical device pharmaceutical biotechnology or automotive manufacturing industries.

• Certifications such as Certified Quality Engineer (CQE) Certified Manager of Quality/Organizational Excellence (CMQ/OE) Six Sigma or equivalent quality credentials.

• Knowledge of 21 CFR Part 820 ISO 13485 and quality tools such as FMEA statistical process control root cause analysis and mistake-proofing methodologies.

• US10: $112900 - $188100 USD Annual

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.