Senior Quality Engineer-Operations-CA

Synchron Inc. • San Diego, CA

36d • $130,000 - $150,000 • Onsite

About The Position

As Senior Quality Engineer (Operations), you will serve as the Quality lead supporting Synchron’s manufacturing operations, contract manufacturers, and supplier network to ensure products are manufactured safely, consistently, and in compliance with applicable regulatory requirements. You will partner closely with Manufacturing Engineering, Supply Chain, Operations, and R&D to establish robust manufacturing processes, support design transfer activities, and drive continuous improvement across production operations. You will also assist in the development and implementation of Synchron’s QMS. This is a hands-on role requiring regular engagement on the manufacturing floor, with suppliers, and across cross-functional teams.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related technical/science field
• 7+ years of quality engineering experience in an FDA-regulated medical device environment, with hands-on experience supporting development and manufacturing of mechanical and/or electrical devices, including process validation and control plan development.

Nice To Haves

• ISO 13485:2016 Lead Auditor Certification (or willingness to obtain); CQE or CQA preferred.
• Ability to read engineering drawings, GD&T, and electrical schematics; hands-on experience with electromechanical assembly and inspection
• Lean manufacturing tools (5S, Kaizen, Statistical Process Control, poka-yoke) and applied statistics (sampling plans, MSA/Gage R&R)
• Working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and applicable product standards (IEC 60601-1, ISO 10993, IEC 62366)
• Supplier quality management experience: auditing, corrective action, and quality agreements
• Strong communicator – able to author clear technical documents and collaborate across R&D, manufacturing, regulatory, and operations
• Ability to work effectively within fast-paced, cross-functional teams with shifting priorities
• 8+ years of medical device quality engineering experience, with 3+ years in a manufacturing environment
• Class III implantable device experience – neuromodulation, vascular, or cardiac rhythm management preferred
• Experience supporting FDA or Notified Body inspections and/or regulatory submissions

Responsibilities

• Serve as the Quality representative supporting manufacturing operations and production readiness.
• Develop and maintain manufacturing quality plans, inspection methods, acceptance criteria, and process controls.
• Monitor production quality metrics including yield, defects, scrap, and process capability; identify trends and drive continuous improvement.
• Support manufacturing investigations related to nonconforming product, deviations, and production issues.
• Lead root cause investigations using structured problem-solving methodologies and ensure timely implementation of effective CAPAs.
• Support Manufacturing Engineering during implementation of new equipment, tooling, automation, and process improvements.
• Lead or support process validation activities (IQ/OQ/PQ) for manufacturing processes, equipment, software, and inspection systems.
• Develop validation protocols, reports, sampling plans, and acceptance criteria.
• Support manufacturing process characterization and statistical analysis.
• Maintain validated state through periodic review and change assessment.
• Participate in pilot builds and production readiness activities supporting commercialization.
• Manage quality oversight of suppliers and contract manufacturers.
• Conduct supplier qualification, audits, performance monitoring, and quality system assessments.
• Review supplier validation documentation, inspection methods, and process controls.
• Maintain supplier quality agreements and supplier performance scorecards.
• Partner with Supply Chain to resolve supplier quality issues and implement corrective actions.
• Partner with R&D and Manufacturing Engineering to ensure successful transfer of new products into production.
• Develop Process FMEAs, Control Plans, inspection strategies, and manufacturing quality documentation.
• Evaluate manufacturing impact of engineering changes through Change Control processes.
• Support Design Reviews with a focus on manufacturability, inspection, process capability, and production scalability.
• Author and maintain manufacturing quality documentation including SOPs, Work Instructions, Inspection Procedures, DHRs, Device Master Records (DMRs), and validation documentation.
• Support internal audits, supplier audits, FDA inspections, and Notified Body audits.
• Ensure manufacturing activities remain compliant with FDA Quality System Regulation, ISO 13485, and applicable international standards.
• Support implementation and continuous improvement of Synchron’s Quality Management System.
• Drive Lean Manufacturing and Operational Excellence initiatives.
• Utilize SPC, capability studies, MSA, Gage R&R, and statistical tools to improve manufacturing performance.
• Develop quality metrics and dashboards to support management review.
• Champion risk-based decision making throughout manufacturing operations.

Benefits

• Subsidized medical and dental insurance coverage for you and your dependent(s)
• Life insurance, short-term disability, long-term disability
• 401k
• Discretionary unlimited PTO
• Flexible Spending Account for you and your dependent(s), with eligible plan elections
• Commuter benefits for NY employees

What This Job Offers

• Job Type: Full-time
• Career Level: Senior