Quality Engineer II – Implantable Devices, Full Lifecycle

Pragmatic; Burlington (MA); Hybrid; USD 100,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

Profit sharing

One remote day per week

Job summary

Pragmatic is seeking a Quality Engineer II for a Class III implantable device program in Burlington, MA. You will own complaint investigations, CAPAs, and support V&V and design controls across product lifecycle.

The candidate should have 18 months to 3.5 years in medical device quality, a bachelor’s in engineering, and hands-on ISO 13485/14971 and 21 CFR 820 experience. On-site four days a week, one day from home, with a competitive base salary.

Qualifications

• 18 months to 3.5 years in medical device quality
• Exposure to V&V or design assurance
• Post-market or complaints experience welcomed

Responsibilities

• Own complaint investigations and CAPAs for a commercial Class III implant
• Support V&V and design controls on new product development
• Build and run inspection protocols for materials and finished product

Skills

Medical device quality

V&V exposure

Design controls

Root cause analysis

Education

Bachelor's in engineering

Job description

Pragmatic is seeking a Quality Engineer II for a Class III implantable device program in Burlington, MA. You will own complaint investigations, CAPAs, and support V&V and design controls across product lifecycle.

The candidate should have 18 months to 3.5 years in medical device quality, a bachelor’s in engineering, and hands-on ISO 13485/14971 and 21 CFR 820 experience. On-site four days a week, one day from home, with a competitive base salary.