Quality Assurance Manager

Arevna; Bakersfield (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Arevna, a growing medical device manufacturing company in California, is seeking an experienced Quality Manager to lead their Quality Management System (QMS). This key role involves overseeing quality assurance, regulatory compliance, and supplier quality while collaborating closely with operations and engineering teams.

The ideal candidate will have over five years of quality leadership experience, extensive knowledge of FDA regulations and ISO 13485 standards, and will drive continuous improvement initiatives within a fast-paced manufacturing environment.

Qualifications

• 5+ years of quality leadership experience in medical device manufacturing.
• Strong knowledge of ISO 13485 and FDA regulations.
• Experience in CAPA and auditing processes.

Responsibilities

• Manage the company's Quality Management System compliant with ISO 13485.
• Lead audits and drive continuous improvement initiatives.
• Prepare for FDA inspections and manage supplier quality.

Skills

Quality leadership experience

Knowledge of ISO 13485

FDA Quality System Regulations

CAPA

Auditing

Supplier Quality Management

Risk management

Cross-functional initiatives

Communication skills

Education

Bachelor's degree in Engineering, Quality, Life Sciences, or a related field

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.