Manager, Quality Assurance (Onsite)

Stryker Group; Ventura (CA); On-site; USD 113,000 - 188,000; Full time

Job summary

Stryker Group is seeking a Manager, Quality Assurance for the TMJ portfolio in Ventura, CA. This onsite role leads QA activities across site operations, collaborating with Operations, Global Quality, Regulatory Affairs, and suppliers to ensure compliant products and processes.

You will develop a QA team, manage audits and CAPA, and drive continuous quality improvements while aligning with business objectives and regulatory requirements.

Qualifications

• Bachelor's degree in engineering, quality, life sciences, manufacturing, or related field.
• 6+ years in technical, manufacturing, quality, or engineering in regulated industry.
• 3+ years leading teams or quality projects.
• Experience in regulated manufacturing with FDA or international quality standards.
• Experience supporting quality systems, audits, corrective actions, and improvements.

Responsibilities

• Lead and develop a team of quality professionals, establishing objectives and quality-focused practices.
• Partner with manufacturing to ensure products meet quality, regulatory, and company requirements.
• Oversee quality system activities including CAPA, change management, validation, investigations, and acceptance.
• Manage regulatory, notified body, customer, and internal audits, ensuring readiness and timely resolutions.
• Develop, monitor, and report quality metrics and use trends to identify improvements.
• Lead quality communications regarding holds, investigations, and field actions with cross-functional teams.
• Implement training programs on regulatory requirements and compliance.
• Support supplier quality activities, continuous improvements, and strategic quality planning.

Skills

Team leadership

Quality assurance

Regulatory compliance

Audits

Process improvement

Education

Bachelor’s degree in Engineering/Quality/Life Sciences/Manufacturing

Job description

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