Quality & Compliance Leader – Medical Devices

ZEISS Group; Exeter (CA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical – 90% employer paid

Dental – 100% employer paid

Life Insurance, AD&D, STD & LTD – 100%

Job summary

ZEISS is seeking a Quality Engineer to act as a hands-on QA resource, ensuring manufacturing aligns with quality and regulatory standards. You will partner with Manufacturing Engineering and can back up quality responsibilities during day-to-day production.

Ideal candidates have 5+ years in QA within medical device or pharma sectors, strong regulatory knowledge, and the ability to manage multiple projects across facilities, including supplier and change management. Travel up to 25%.

Qualifications

• Solid understanding of quality system requirements per major regulatory frameworks for medical devices and combination products.
• Experience managing quality in distribution, preferably for disposable devices and pharma products.
• Ability to translate quality requirements into practical directions.

Responsibilities

• Identify and assist with process validation activities.
• Support manufacturing layout/process projects for efficiency and timely completion.
• Manage multiple projects across production stages including process improvements and quality inspections.
• Lead PFMEA risk management activities and verification of mitigation implementations.
• Support design transfer to manufacturing and QA activities from production to shipment.
• Inspect product labeling and documentation for release of finished goods.
• Ensure production staff are trained on manufacturing procedures and follow them.
• Review and validate changes to procedures.
• Oversee creation and review of documentation for nonconforming products.
• Provide QA support in investigation of nonconformances and CAPAs.
• Coordinate with Engineering on engineering change orders affecting production.
• Keep management informed of significant QA issues and corrective actions.
• Assist with revisions to quality procedures and work instructions.
• Participate in supplier quality management and report issues.
• Participate in audits (ISO, Notified Body, FDA, etc.).
• Support other duties as assigned.

Skills

Quality systems

Regulatory knowledge

Cross-functional collaboration

Project management

English proficiency

Education

Bachelor's degree in engineering

Quality Assurance certification (Six Sigma, Lean, ASQ)

Tools

Microsoft Office

Job description

ZEISS is seeking a Quality Engineer to act as a hands-on QA resource, ensuring manufacturing aligns with quality and regulatory standards. You will partner with Manufacturing Engineering and can back up quality responsibilities during day-to-day production.

Ideal candidates have 5+ years in QA within medical device or pharma sectors, strong regulatory knowledge, and the ability to manage multiple projects across facilities, including supplier and change management. Travel up to 25%.