Senior Quality & Compliance Manager – Medical Devices

Carl Zeiss GmbH; New Britain (CT); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical – 90% employer paid

Dental – 100% employer paid

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

Vision

401k Matching

Paid Sick, Vacation, Holidays

Job summary

ZEISS in New Britain, PA, seeks a Quality Engineer to ensure manufacturing quality aligns with regulatory standards. The role collaborates with Manufacturing Engineering, supports process validation, risk management, inspections, and CAPAs, and may travel up to 25% to New Britain and Exeter/Seabrook locations.

Qualified candidates will have a minimum 5 years in QA for medical devices or pharma, a bachelor’s degree in engineering, and experience with FDA inspections and document control.

Qualifications

• Experience applying quality systems in medical devices or pharma.
• Ability to translate quality requirements into actionable guidance.
• Proven track record with FDA inspections and regulatory audits.
• Strong documentation and CAPA management skills.

Responsibilities

• Identify and support process validation activities.
• Assist with plant layout/process projects for efficiency and timeliness.
• Lead or support PFMEA and risk management activities.
• Oversee design transfers to manufacturing and QA release activities.
• Inspect labeling and documentation for finished goods release.
• Ensure procedures are followed and changes are properly validated.

Skills

Quality engineering

FDA inspections

CAPA investigations

PFMEA

Documentation control

Cross-functional collaboration

English communication

Education

Bachelor's degree in engineering

Job description

ZEISS in New Britain, PA, seeks a Quality Engineer to ensure manufacturing quality aligns with regulatory standards. The role collaborates with Manufacturing Engineering, supports process validation, risk management, inspections, and CAPAs, and may travel up to 25% to New Britain and Exeter/Seabrook locations.

Qualified candidates will have a minimum 5 years in QA for medical devices or pharma, a bachelor’s degree in engineering, and experience with FDA inspections and document control.