Manager, Quality Engineering

Work Flexibility: Onsite

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. This role is Onsite in Mahwah New Jersey.

• Lead the Quality Assurance team providing technical guidance and quality oversight across manufacturing and operations supports functions to drive continuous improvement and compliance.
• Partner with site leadership to ensure products consistently meet customer expectations regulatory requirements and applicable quality standards.
• Develop coach and retain a high-performing team while fostering a culture of inclusion accountability collaboration and employee engagement.
• Drive quality system compliance by partnering with functional leaders to establish communicate and maintain quality standards requirements and responsibilities.
• Lead site readiness activities and support internal corporate notified body FDA and other regulatory audits and inspections.
• Oversee the management of nonconforming products product and process deviations risk assessments corrective actions and preventive actions to ensure effective resolution and compliance.
• Monitor and improve Quality performance indicators including NCR CAPA compliance and operational quality metrics and implement corrective actions for adverse trends.
• Support the development and execution of local and global Quality Operations strategies that improve product quality operational efficiency risk management and regulatory compliance.

• 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.

• Masters degree in Business Management Engineering Science or an MBA.
• Experience leading and developing high-performing quality teams in a manufacturing environment.
• Experience establishing quality strategies and performance improvement programs across multiple sites or business units.
• Black Belt Green Belt or equivalent Lean/Six Sigma certification.
• Experience supporting global quality systems regulatory compliance initiatives and continuous improvement programs.
• Experience influencing cross-functional stakeholders and driving quality culture initiatives.
  
  

United States of America Pay Ranges:

• US20: $141600 - $236000 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

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.