Senior Quality Assurance Manager, Medical Devices

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

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.