Quality Engineer II — Shape Med Device Quality (On-site)

TEI BIOSCIENCES INC; Braintree (MA); On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life Insurance

Disability Insurance

401(k) Savings Plan

Job summary

Integra LifeSciences is seeking a Quality Engineer II to independently support manufacturing and engineering to ensure safe, compliant medical devices. You will own investigations, CAPAs, risk management, and validation support while collaborating with Manufacturing, Engineering, and Regulatory Affairs.

Required is a Bachelor's in Engineering or Life Science, 3+ years in a regulated environment, and experience with FDA/ISO quality standards.

Qualifications

• Bachelor's degree in Engineering (Biomedical/Mechanical/Chemical/Electrical) or Life Science.
• 3+ years quality engineering in a regulated manufacturing environment (or 1–2 years with a Master's).
• Medical device industry experience.
• Experience applying FDA/ISO quality standards in regulated device environments.
• Experience owning nonconformances, investigations, CAPAs, and change controls.

Responsibilities

• Ensure compliance with cGMP, FDA QSR, ISO 13485, ISO 9001, MDR/CMDR and internal procedures.
• Own/close investigations, nonconformances, and CAPAs of moderate complexity.
• Lead or support validation activities for processes, tests, and equipment.
• Support MRB reviews and disposition of nonconforming material.
• Lead pFMEA and risk management activities; support process changes.
• Prepare quality data and metrics for management review.

Skills

Regulatory knowledge

Quality data analysis

DOE/Statistics

Cross-functional collaboration

MS Office, QMS, ERP

Education

Bachelor's degree in Engineering or Life Science

Tools

Minitab

QMS & ERP systems

Job description

Integra LifeSciences is seeking a Quality Engineer II to independently support manufacturing and engineering to ensure safe, compliant medical devices. You will own investigations, CAPAs, risk management, and validation support while collaborating with Manufacturing, Engineering, and Regulatory Affairs.

Required is a Bachelor's in Engineering or Life Science, 3+ years in a regulated environment, and experience with FDA/ISO quality standards.