Quality Engineer (QMS)

Quality Engineer (QMS)

Join Beacon Biosignals to maintain and improve compliance of its Quality Management System (QMS) across worldwide operations.

Responsibilities

• Maintain and improve QMS compliance for the organization.
• Support and uphold a 21 CFR Part 820 and ISO 13485-compliant QMS, including:
  • Drafting, revising, reviewing, and approving quality procedures.
• Perform supplier qualification activities, including evaluations and audits.
• Work with suppliers to manage:
  • Changes
  • Nonconformances
  • Corrective and preventive actions (CAPA)
• Ensure compliance with training and documentation requirements.

Requirements

• Bachelor’s degree in a relevant scientific/technical field (e.g., Biomedical, Electrical, Systems Engineering) or equivalent.
• 5+ years of quality management experience in a regulated environment.
• Experience following ISO 13485:2016 and 21 CFR Part 820.
• Experience auditing and participating in audits.
• Strong analytical, organizational, and communication skills; ability to adapt to changing circumstances.
• Ability to manage multiple projects simultaneously and prioritize based on risk.
• Proven ability to work autonomously with hands-on problem-solving.

Nice to have

• Experience with electronic Quality Management Systems (eQMS).
• Relevant quality certifications such as:
  • Certified Quality Auditor
  • Certified Quality Engineer
  • Certified Software Quality Engineer

Location / Work model

• Full remote (Boston, US referenced in posting).