Senior Quality Engineer, Medical Device Manufacturing Ops

Synchron; San Diego (CA); On-site; USD 130,000 - 150,000; Full time

Benefits offered by this job

Healthcare and dental insurance

401(k)

Discretionary PTO

Commuter benefits

Job summary

Synchron is seeking a Senior Quality Engineer (Operations) in San Diego to lead manufacturing quality, support design transfer, and drive continuous improvement across production. You will collaborate with Manufacturing Engineering, Supply Chain, Operations, and R&D to ensure products are manufactured safely, consistently, and in compliance with regulatory requirements.

The role requires hands-on engagement on the floor and with contract manufacturers, including development of QMS, validation

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Electrical Engineering, or related field.
• 7+ years of quality engineering experience in FDA-regulated medical devices.
• Hands-on support for development and manufacturing with process validation.

Responsibilities

• Manufacturing Quality: serve as Quality representative, develop quality plans and process controls.
• Process Validation & Manufacturing Readiness: lead IQ/OQ/PQ activities and validation docs.
• Supplier & Contract Manufacturer Quality: oversee supplier quality and audits.
• Design Transfer & Change Management: ensure successful transfer to production and documentation.
• Quality Systems & Compliance: maintain SOPs, prepare for audits and regulatory submissions.
• Continuous Improvement: drive Lean, SPC, and risk-based decision making.

Skills

Quality engineering

Regulatory compliance

Root cause analysis

CAPA investigations

Cross-functional collaboration

Education

Bachelors in Mechanical Engineering

Bachelors in Biomedical Engineering

Bachelors in Electrical Engineering

Tools

FMEA

Change Control

MSA/Gage R&R

QMS documentation

Job description

Synchron is seeking a Senior Quality Engineer (Operations) in San Diego to lead manufacturing quality, support design transfer, and drive continuous improvement across production. You will collaborate with Manufacturing Engineering, Supply Chain, Operations, and R&D to ensure products are manufactured safely, consistently, and in compliance with regulatory requirements.

The role requires hands-on engagement on the floor and with contract manufacturers, including development of QMS, validation