Manager, Quality Engineer

Proven Recruiting; San Diego (CA); On-site; USD 103,320 - 137,760; Full time

Job summary

Proven Recruiting in San Diego, CA, seeks a hands-on Manager of Quality Engineering to lead QA across product development, compliance, and operations in the medical device space. This contract role demands driving CAPA, validation, and supplier quality initiatives while mentoring engineers.

The ideal candidate has 5+ years in regulated environments, a relevant engineering degree, and strong Six Sigma/DOE skills. The role pays $75–$100 per hour and offers opportunities to shape quality programs.

Qualifications

• Bachelor’s degree in Mechanical, Chemical, Biomedical Engineering, or related discipline.
• 5+ years of experience in medical devices or a regulated ISO/cGMP/GLP environment.
• Strong expertise in Six Sigma, DOE, and root cause analysis.
• Experience with IQ/OQ/PQ validation and CAPA investigations.
• Experience supporting complaint handling, risk management (ISO 14971), and supplier quality.

Responsibilities

• Lead and mentor Quality Engineers, driving technical development and team performance.
• Oversee quality activities across new product development, maintenance, and compliance.
• Develop and execute validation protocols, test methods, and sampling plans.
• Drive investigations, CAPA execution, and supplier quality improvements.
• Support audits, regulatory inspections, and continuous improvement initiatives.

Skills

Quality engineering leadership

Six Sigma

DOE

Root cause analysis

Education

Bachelor’s degree in Mechanical, Chemical, Biomedical Engineering

Job description

Manager, Quality Engineering, San Diego, CA. $75–$100/hr (Contract role)

Are you a hands‑on quality engineering leader ready to drive impact in the medical device space? Our client, an innovative and growing medical device company, is seeking a leader to oversee quality engineering initiatives across product development, compliance, and operational excellence.

Who you are:

• 5+ years of experience in medical devices or a regulated ISO/cGMP/GLP environment
• Bachelor’s degree in Mechanical, Chemical, Biomedical Engineering, or related discipline
• Strong expertise in statistical methods (Six Sigma, DOE) and root cause analysis
• Proven experience with validation (IQ/OQ/PQ), CAPA investigations, and regulatory compliance (ISO, ASTM)
• Experience supporting complaint handling, risk management (ISO 14971), and supplier quality

What you’ll do:

• Lead and mentor Quality Engineers, driving technical development, team performance, and succession planning
• Oversee quality activities across new product development, product maintenance, and compliance initiatives
• Develop and execute validation protocols, test methods, and statistically sound sampling plans
• Drive investigations, CAPA execution, supplier quality improvements, and complaint analysis
• Support audits, regulatory inspections, and continuous improvement initiatives aligned with business goals

What does this position pay?

Compensation is determined by several factors which may include skillset, experience level, and education. The expected range for this role is $75–$100 per hour. Please note this range is an estimate and actual pay may vary based on qualifications and experience.

We actively support and promote people of various backgrounds, from race, religion, gender to geographical area, university, lifestyle, and personality type. Proven Recruiting is minority‑owned, majority women, and is a strong advocate for diversity and inclusion in the broader community.