Beacon Biosignals
Precision Medicine
QualityEngineer,QMS
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Engineer, QMS at Beacon Biosignals. Skills: Quality Management System, ISO 13485, 21 CFR Part 820. Support compliant QMS. Draft, revise, review, approve procedures”
What You'll Achieve.
Maintain and improve compliance of QMS; Ensure company compliance with training
Industry & Context.
Problem solving expertise; Analytical skills
What They're Looking For.
Must Have
Bachelor’s degree in relevant scientific/technical field, 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, hands-on problem solving expertise, analytical skills, Exceptional interpersonal and relationship-building abilities, talent for managing projects, guiding decisions across multiple internal and external stakeholders, analytical skills, organizational skills, communication skills, demonstrated ability to adapt effectively to changing circumstances, Ability to handle multiple projects simultaneously, prioritizing based on risk
Nice to Have
Certified Quality Auditor, Certified Quality Engineer, Certified Software Quality Engineer
What You'll Do.
Support compliant QMS
Qualify and approve suppliers
Address supplier changes
Implement corrective actions
Perform supplier qualification
Maintain QMS processes
Manage employee training
Ensure timely deviation closure
Improve compliance processes
Manage audit scheduling
Manage customer audits
Manage external audits
How You'll Work.
Team & Collaboration
Work with internal stakeholders; Work with suppliers; Interact with every Beaconeer; Guide decisions across stakeholders
Communication Scope
Communication skills
Process & Methodology
Manage projects, Prioritize based on risk, Handle multiple projects
Full Job Description
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). 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 th
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