Quality Engineer (Medical Device is a MUST)

Proven Recruiting; San Diego (CA); On-site; USD 68,880 - 103,320; Full time

Job summary

Proven Recruiting is seeking a Quality Engineer in San Diego specializing in medical devices. This contract role involves driving quality, validation, and investigation work across R&D and manufacturing. Candidates should have 3-7+ years of experience in a regulated environment and a degree in Engineering.

The position offers competitive pay between $50 and $75 per hour based on experience, appealing to those with strong validation and statistical background.

Qualifications

• 3-7+ years of experience in medical devices or a regulated ISO/cGMP/GLP environment.
• Working knowledge of ASTM, ISO, and ICH standards.
• Prefer class 3 medical device experience.

Responsibilities

• Develop and execute validation protocols and test methods.
• Lead product investigations, CAPAs, and supplier quality issues.
• Perform statistical analysis and support risk management.

Skills

Validation experience (IQ/OQ/PQ)

Statistical methods (Six Sigma, DOE)

Attention to detail

Problem-solving mindset

Education

Bachelor’s degree in Engineering

Job description

Quality Engineer (Medical Device is a MUST)

San Diego, CA, $50–$75/hr

Looking for a contract role where you can drive quality, validation, and investigation work end-to-end? Our client, an innovative medical device organization, is seeking a hands‑on Quality Engineer to support testing, compliance, and CAPA efforts with strong visibility across R&D and manufacturing.

Who you are

• Bachelor’s degree in Engineering with 3-7+ years of experience in medical devices or a regulated ISO/cGMP/GLP environment
• Strong experience with validation (IQ/OQ/PQ), statistical methods (Six Sigma, DOE), and complaint/CAPA investigations
• Working knowledge of ASTM, ISO, and ICH standards with a strong attention to detail and problem-solving mindset. Prefer class 3 medical device experience.

What you’ll do

• Develop and execute validation protocols, test methods, sampling plans, and calibration procedures
• Lead product investigations, CAPAs, and supplier quality issues, including complaint analysis and trend evaluation
• Perform statistical analysis and support risk management, audits, and cross‑functional quality initiatives

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 $50–$75 per hour. Please note this range is an estimate and actual pay may vary based on qualifications and experience.

What’s next?

Please email your resume to [e-mail] if you’re excited to explore this opportunity with our client.

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.