Quality Engineer, QMS

This Quality Engineering role reports to the VP of Quality and is responsible for maintaining and improving compliance of the Quality Management System used at Beacon Biosignals worldwide. The position will be located in the US, preferably in or near a Beacon hub (Boston or New York).

What success looks like:

• Support of a 21 CFR Part 820 and ISO 13485 compliant quality management system (QMS) including drafting, revising, reviewing and approving procedures
• Work with internal stakeholders on the qualification and approval of suppliers. Work with suppliers to address changes, nonconformances, and implement corrective actions, as necessary
• Perform supplier qualification activities, including evaluations and audits
• Maintain QMS processes in compliance as assigned by QA leadership including but not limited to nonconformity management, CAPA management, deviation management, employee training.
• Maintains CAPAs and Corrections in compliance with respect to due dates, ensures tasks are completed on time and items are recorded appropriately by responsible personnel.
• Ensures company is compliant with training completion and on time training completion by following up with personnel who are not compliant
• Ensures deviations are opened and closed in a timely manner and documentation is compliant
• Improve processes for compliance, implementing the least burdensome approach
• Manage scheduling, coordination, and meetings for audits with external parties and internal Subject Matter Experts. Manage audit results/reports, and any actions that arise from audits
• Manage all tasks related to customer and external audits

What you will bring:

• Bachelor’s degree in relevant scientific/technical field such as Biomedical, Electrical, Systems Engineering or equivalent 5 years experience in a regulated industry
• 5+ years quality management experience in a regulated environment following ISO 13485:2016 and 21CFR Part 820
• Experience with electronic Quality Management Systems (eQMS)
• Certified Quality Auditor, Certified Quality, Engineer or Certified Software Quality Engineer desired, but not required
• Experience auditing and being audited
• Proven ability to work autonomously with hands-on problem solving expertise and strong analytical skills
• Exceptional interpersonal and relationship-building abilities, with a talent for managing projects and guiding decisions across multiple internal and external stakeholders.
• Strong analytical, organizational, and communication skills, with a demonstrated ability to adapt effectively to changing circumstances
• Ability to handle multiple projects simultaneously, prioritizing based on risk
• Strong team player, as this position interacts with every Beaconeer