Quality Assurance Manager

Arevna; Bakersfield (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Arevna Limited in California seeks an experienced Quality Manager to lead the Quality Management System for precision medical components and ensure regulatory compliance with ISO 13485 and FDA requirements.

You will drive CAPA, audits, supplier quality, validation, risk management and continuous improvement, partnering with Operations, Engineering and Regulatory Affairs while mentoring teams and preparing for inspections.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline.
• 5+ years of quality leadership experience in regulated medical device manufacturing.
• Strong knowledge of ISO 13485.
• FDA QSR 21 CFR Part 820.
• Experience with CAPA, audits, supplier quality management.
• Experience leading cross-functional quality improvement initiatives.
• Excellent communication and stakeholder management skills.

Responsibilities

• Maintain the Quality Management System in compliance with ISO 13485 and FDA regulations.
• Lead internal, supplier, and customer audits and drive corrective actions.
• Drive CAPA, nonconformance, complaint handling, and root cause analysis.
• Develop quality documentation, procedures, records, and inspection readiness.
• Develop quality metrics, KPIs, and management review activities.
• Partner with Operations and Engineering to improve product quality and process capability.
• Support validation activities, risk management, and training.

Skills

ISO 13485

FDA QSR 21 CFR 820

CAPA

Auditing

Supplier Quality

Validation & Risk Mgmt

Cross-functional collab

Education

Bachelor's degree in Engineering/Quality/Life Sciences

Job description

Medical Device Manufacturing | California, USA

About the Opportunity

A growing medical device manufacturing company is seeking an experienced Quality Manager to lead and continuously improve its Quality Management System (QMS). This is a key leadership role supporting the manufacture of precision medical components used in critical healthcare applications.

The successful candidate will oversee quality assurance activities, regulatory compliance, supplier quality, audits, CAPA programs, and continuous improvement initiatives while partnering closely with Operations, Engineering, and Regulatory Affairs.

Key Responsibilities

• Manage and maintain the company's Quality Management System in compliance with ISO 13485 and applicable FDA regulations.
• Lead internal, supplier, and external audits, including certification and customer audits.
• Drive CAPA, nonconformance, complaint handling, and root cause investigation processes.
• Ensure quality documentation, procedures, and records remain inspection-ready.
• Develop and monitor quality metrics, KPIs, and management review activities.
• Partner with manufacturing and engineering teams to improve product quality and process capability.
• Manage supplier qualification, supplier performance monitoring, and quality agreements.
• Support validation activities, process controls, and risk management initiatives.
• Lead training programs related to quality systems and regulatory compliance.
• Prepare for and support FDA inspections and customer quality assessments.
• Foster a culture of continuous improvement and operational excellence.

Required Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
• 5+ years of quality leadership experience within a regulated medical device manufacturing environment.
• Strong working knowledge of:
• ISO 13485
• FDA Quality System Regulations (21 CFR Part 820)
• CAPA
• Internal and external auditing
• Supplier Quality Management
• Validation and risk management principles
• Experience leading cross-functional quality improvement initiatives.
• Excellent communication and stakeholder management skills.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar certification.
• Experience with extrusion, catheter, tubing, polymer, or component manufacturing.
• Experience supporting FDA inspections and notified body audits.
• Familiarity with statistical process control and quality data analysis.

What You'll Bring

• Hands-on leadership style.
• Strong problem‑solving and root cause analysis skills.
• Ability to influence across functions and drive accountability.
• Passion for building robust quality systems in a fast-paced manufacturing environment.