Manager, Quality Assurance (Onsite)

Stryker Corporation; California, Northern (MO, KY); Hybrid; USD 113,000 - 188,000; Full time

Job summary

Stryker Corporation in Ventura, California, is seeking a Manager, Quality Assurance for the TMJ portfolio. This onsite role leads quality teams, drives product quality, audits readiness, and continuous improvement across site operations.

You will collaborate with Operations, Global Quality, Regulatory Affairs, and suppliers to ensure compliance with FDA/ISO standards, manage audit programs, and report quality metrics. A bachelor’s degree and 6+ years in a regulated industry are required.

Qualifications

• Bachelor’s 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.

Responsibilities

• 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 meet quality and regulatory 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 and quality processes.
• Support supplier quality activities, continuous improvement initiatives, acquisition integrations, budgeting activities, and strategic quality planning.

Skills

Leadership

Quality Assurance

Regulatory Compliance

Audit Management

Process Improvement

Cross-functional Collaboration

Education

Bachelor’s degree in Engineering, Quality, Life Sciences, Manufacturing, or related

Tools

FMEA

Statistical Process Control

Root Cause Analysis

Mistake-Proofing

Job description

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 Stryker's 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 Bachelor’s 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: $112,900 - $188,100 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 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. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces!

For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements.

Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.