Quality Engineer II: Medical Device QA & Improvement

Pramand-LL; Bedford (MA); On-site; USD 70,000 - 100,000; Full time

Job summary

Pramand, LLC, based in Bedford, MA, is seeking a Quality Engineer II to support QA/QC for implantable medical devices. You will lead day-to-day quality activities, participate in design controls, and ensure compliance with cGMP, ISO 13485, and 21 CFR Part 820.

You will collaborate with manufacturing and R&D to maintain robust process controls, perform root-cause analysis, and contribute to continuous improvement initiatives in a regulated environment.

Qualifications

• Bachelor’s degree in scientific/engineering or equivalent work experience.
• 2–4 years of experience in a regulatory and/or controlled environment (medical device/pharma/biomedical).
• Excellent organizational skills and attention to detail.
• Strong technical background, scientific judgment, customer focus, initiative.
• Familiar with FDA QMSR and ISO 13485 requirements.

Responsibilities

• Manufacturing Quality Support: establish quality standards, inspection protocols, and real-time QA aid to manufacturing.
• Design & Development Support: assist with verification/validation activities and design changes as needed.
• Quality System & Compliance: support cGMP, ISO 13485, CAPA, audit trails and regulatory requirements.
• General: collaborate across teams to resolve issues and drive corrective actions.
• Quality metrics tracking for continuous improvement.

Skills

Quality Assurance

Quality Control

Root Cause Analysis

CAPA

Documentation

FDA QMSR

ISO 13485

MS Office

Excel

Education

Bachelor's degree in scientific/engineering

Tools

MS Office

Excel

Job description

Pramand, LLC, based in Bedford, MA, is seeking a Quality Engineer II to support QA/QC for implantable medical devices. You will lead day-to-day quality activities, participate in design controls, and ensure compliance with cGMP, ISO 13485, and 21 CFR Part 820.

You will collaborate with manufacturing and R&D to maintain robust process controls, perform root-cause analysis, and contribute to continuous improvement initiatives in a regulated environment.