Quality Engineer II: Med Device Quality & Compliance

Pramand LLC; Bedford (MA); On-site; USD 75,000 - 110,000; Full time

Job summary

Pramand LLC in Bedford, MA is seeking a Quality Engineer II to join our medical device team. You will perform day-to-day QA, QC and quality engineering tasks for implantable devices, supporting manufacturing and continuous improvement initiatives.

Responsibilities include inspecting materials and processes, maintaining quality documentation, participating in CAPA and change control, and collaborating with R&D and production to ensure compliance with cGMP, ISO 13485 and 21 CFR Part 820.

Qualifications

• Bachelor’s degree in scientific/engineering field.
• 2–4 years in regulated medical device or similar setting.
• Strong attention to detail and organizational skills.
• Excellent communication and problem-solving abilities.
• Experience with cGMP and ISO 13485 a plus.
• Proficient with MS Office.

Responsibilities

• Develops and maintains quality standards and inspection protocols.
• Conduct incoming, in-process, and final inspections.
• Provide QA support to manufacturing operations and investigations.
• Support product verification, validation, and changes to designs.
• Assist in maintaining compliance with cGMP, ISO 13485, and 21 CFR 820.
• Track quality metrics and drive continuous improvement.

Skills

Quality Assurance

Quality Control

Regulatory Compliance

Documentation

Root Cause Analysis

Education

Bachelor's degree in science/engineering

Tools

MS Office

Quality Management System (QMS)

Job description

Pramand LLC in Bedford, MA is seeking a Quality Engineer II to join our medical device team. You will perform day-to-day QA, QC and quality engineering tasks for implantable devices, supporting manufacturing and continuous improvement initiatives.

Responsibilities include inspecting materials and processes, maintaining quality documentation, participating in CAPA and change control, and collaborating with R&D and production to ensure compliance with cGMP, ISO 13485 and 21 CFR Part 820.