Quality Assurance Manager - Simi Valley, CA

Join Robert Half's esteemed client in Simi Valley, California, as a Quality Assurance Manager in a cutting-edge medical device manufacturing environment. This pivotal role focuses on developing, implementing, and maintaining a robust ISO 13485-compliant Quality Management System (QMS). If you have a passion for regulatory compliance, product quality, and driving continuous improvement in the medical device industry, this position offers an exciting opportunity to make a significant impact. Located in the heart of Simi Valley, CA, this full-time role combines strategic oversight with hands-on leadership to ensure the highest standards of safety and efficacy for life-saving devices.

About the Role

As the Quality Assurance Manager, you will act as the cornerstone of quality excellence, collaborating with cross-functional teams including engineering, manufacturing, and regulatory affairs. Your expertise will be crucial in upholding stringent regulatory requirements from bodies like the FDA and international standards such as ISO 13485. This position demands a proactive leader who thrives in a regulated environment, adept at navigating complex audits, managing recalls, and fostering a culture of compliance. With Simi Valley's proximity to Los Angeles tech hubs, you'll enjoy a dynamic work setting that supports innovation while prioritizing patient safety. Robert Half places top talent in roles like this, ensuring you partner with forward-thinking organizations committed to medical advancements.

Key Responsibilities

Your day-to-day will involve high-impact tasks essential to quality assurance in medical devices:

• Serve as the primary Management Representative, overseeing the entire QMS to guarantee unwavering compliance with ISO 13485 and other regulations.
• Lead coordination of internal audits and external inspections, preparing teams and implementing corrective actions swiftly.
• Develop and deliver comprehensive staff training programs on quality procedures, GMP, and regulatory updates to build a compliant workforce.
• Orchestrate product recalls end-to-end, from initiation through closure, maintaining meticulous records for regulatory scrutiny.
• Execute post-market surveillance, vigilantly monitoring device performance and updating Device Master Records (DMRs) for ongoing safety.
• Ensure timely submission of reportable events like MDRs and vigilance reports to regulatory authorities.
• Manage renewals of medical device licenses and registrations across domestic and international jurisdictions.
• Analyze quality metrics, trends, and data to craft compelling management review presentations that drive process enhancements.
• Oversee the document change order (DCO) process, ensuring all procedures, work instructions, and inspection documents are accurately updated and controlled.

These responsibilities position you at the forefront of quality leadership, directly influencing product integrity and company reputation.

Required Qualifications

To excel in this role, candidates should possess:

• A Bachelor's degree in Engineering, Quality Management, Life Sciences, or a related discipline; advanced certifications like CQA or Six Sigma Black Belt are highly preferred.
• At least 5-7 years of progressive experience in quality assurance, ideally within FDA-regulated medical device manufacturing.
• Deep expertise in ISO 13485, 21 CFR Part 820, and EU MDR/IVDR requirements.
• Demonstrated success as a Quality Management Representative, with a track record of successful audits (e.g., FDA, Notified Body).
• Proven skills in handling recalls, CAPA systems, and post-market activities.
• Strong analytical abilities for metrics-driven decision-making and root cause analysis.
• Excellent interpersonal skills for training, cross-functional collaboration, and stakeholder communication.
• Familiarity with electronic QMS software (e.g., MasterControl, Greenlight Guru) and Microsoft Office Suite.

ASQ certification and experience in risk management (ISO 14971) will set you apart in this competitive field.

Why Join Us?

Partnering with Robert Half means accessing unparalleled career support in Simi Valley's thriving biotech sector. Enjoy a competitive salary around $98,900 annually (based on $47.58/hour for full-time), plus comprehensive benefits including health coverage, 401(k) matching, PTO, and professional growth opportunities. Our client offers a collaborative culture, state-of-the-art facilities, and the chance to contribute to innovative medical devices that improve lives. SEO-optimized for careers in Quality Assurance Manager jobs Simi Valley CA, ISO 13485 medical device roles, and Robert Half placements, this is your gateway to long-term success. Apply now and elevate your career in quality assurance!

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