Quality Engineer, QMS

Beacon Biosignals•Boston, MA

1d•Hybrid

About The Position

Beacon Biosignals is on a mission to revolutionize precision medicine for the brain. We are the leading at-home EEG platform supporting clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our FDA 510(k)-cleared Waveband EEG headband and AI algorithms enable quantitative biomarker discovery and implementation. Beacon’s Clinico-EEG database contains EEG data from nearly 100,000 patients, and our cloud-native analytics platform powers large-scale RWD/RWE retrospective and predictive studies. Beacon Biosignals is changing the way that patients are treated for any disorder that affects brain physiology. 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).

Requirements

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)
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

Nice To Haves

Certified Quality Auditor, Certified Quality, Engineer or Certified Software Quality Engineer desired, but not required

Responsibilities

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