Director/VP of Quality Assurance

Boston              ·              Full time

What you will be doing: 

The Director/VP of Quality Assurance, reporting to the Chief R&D Officer, will be a seasoned quality and compliance expert who is motivated to join and thrive at a start-up company in the fast-paced growth market of AI-driven medical technologies and diagnostics. 

Key responsibilities and deliverables include implementing the QMS; ensuring compliance with HIPAA, ISO, and GCP; creative problem-solving with engineers; setting strategy with regulatory and other key functional areas; representing the company to big pharma partners and other stakeholders; and growing the department in step with the company’s growth. 

The right candidate will be an experienced quality and compliance expert who is proactive, able to identify and set objectives, communicates well across the company, can flex with a fast-moving company, and shares our goal-oriented, “roll up the sleeves” mindset.

What success looks like: 

• Lead the development, implementation, and maintenance of Beacon Biosignals’ CFR Part 820-compliant Quality Management System (QMS) in alignment with the company’s evolving growth
• Support implementation of policies, procedures and practices to ensure  HIPAA, ISO, and GCP-compliance
• Serve as a business partner to the commercial operations of Beacon
• Successfully and efficiently plan and execute activities necessary to ensure compliance with FDA and other applicable health authorities
• Collaborate with technical teams to develop compliant design and quality procedures compatible with agile development models
• Ensure Design Control procedures are fit-for-purpose and followed.
• Interface externally with auditors, partners, regulators, and others as a credible, influential, and respected thought leader and company spokesperson
• Lead and complete all vendor audits and compliance assessments
• Provide guidance/input for new product planning and clinical trial design
• Establish and promote a quality-driven product development culture in the organization
• Provide training and ensure company-wide compliance with CFR Part 820, Part 11, ISO 13485 and other applicable regulations in the United States and potentially globally
• Understand relevant industry trends and guide leadership accordingly
• Build the QA and compliance department by hiring, managing, and mentoring staff
• Interface and collaborate with Regulatory Affairs

What you will bring: 

• 7+ years of experience in quality, compliance and/or regulatory affairs.
• Demonstrated passion for improving healthcare
• Prior successful experience establishing QA and compliance processes for a clinical diagnostic (software as a significant component or SaMD) company is required
• Knowledge of the FDA clearance process (including registration, pre-sub, 510(k), PMA) and CE marking are highly desirable
• Experience implementing eQMS strongly preferred
• Diagnostic and AI-software experience strongly preferred
• Successful start-up experience preferred
• Strong documentation skills covering all QMS compliance and FDA matters
• Good personal network of contacts in health software RA and QA fields that can be leveraged to determine and implement new best practices, anticipate regulatory developments, and others
• Successful track record of working well internally (including across groups) and externally with regulators and other stakeholders
• Outstanding communication, presentation, and leadership skills
• Experience building a team of quality professionals
• Experience with medical device product labeling, design transfer into manufacturing, and solid understanding of manufacturing operations

At Beacon, we’ve found that cultural and scientific impact is driven most by those that lead by example. As such, we’re always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and – most of all – a deep empathy towards colleagues, stakeholders, users, and patients. We believe a diverse team builds more robust systems and achieves higher impact.

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