Quality Assurance Engineer
PAVmed Inc.
- Foxborough, Massachusetts, United States
- Foxborough, Massachusetts, United States
À propos
PAVmed Inc. is a diversified commercial‑stage medical technology company operating in the medical device, diagnostics, and digital health sectors. The company focuses on advancing innovative technologies that address significant unmet clinical needs and improve patient outcomes. Its portfolio includes Lucid Diagnostics, a cancer prevention diagnostics company, and Veris Health Inc., a digital health company focused on personalized cancer care through remote patient monitoring.
Benefits & Company Culture
Comprehensive Benefits: top‑tier medical, dental, and vision coverage; 98% of employee healthcare premiums paid by the company; company‑paid basic life insurance; short‑ and long‑term disability coverage.
Financial Wellness: 401(k) match with immediate vesting and an Employee Stock Purchase Program (ESPP).
Rest, Recharge, and Give Back: paid vacation, sick days, 12 company holidays, and a dedicated volunteer day.
Professional Growth: ongoing learning opportunities, hands‑on training, and clear pathways for advancement.
Wellbeing Support: employee assistance programs, wellness initiatives, and gym reimbursement.
A Winning Culture: recognized as one of GenomeWeb’s 2025 Best Places to Work, celebrating collaboration and innovation daily.
Key Responsibilities
Supports and maintains QMS processes, including audits, complaints, CAPA, and change control activities.
Owns and manages the Document Control process, ensuring timely and compliant document lifecycle management.
Manages the training program, including maintenance of training matrices and records, and rollout of procedure‑based and role‑based training.
Supports supplier quality activities, including supplier qualification, performance monitoring, and maintenance of the approved supplier list (ASL).
Supports eQMS implementation activities such as data migration, validation support, user acceptance testing, and acts as a liaison between the organization and the eQMS vendor.
Reviews and analyzes QMS metrics and performance indicators, preparing reports to identify trends, nonconformances, and improvement opportunities.
Assists in development, implementation, and revision of QMS procedures, SOPs, work instructions, and quality documentation.
Participates in risk assessment activities and supports the development of mitigation plans.
Contributes to continuous improvement initiatives by identifying process enhancements and supporting implementation of quality system improvements.
Collaborates cross‑functionally to resolve quality issues, support investigations, and implement corrective and preventive actions.
Supports internal and external audits by preparing documentation, coordinating audit activities, and assisting with audit observations.
Maintains effective working relationships with internal teams and external stakeholders to support quality objectives and compliance activities.
Proactively maintains knowledge of industry standards, regulatory requirements, and company quality procedures.
Occasional travel for team meetings, conferences, and vendor visits.
Performs other quality system duties as assigned in support of the company’s quality objectives.
Qualifications
Education: Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
Experience: 3+ years in FDA‑regulated and/or ISO 13485 medical device manufacturing or quality environments.
Knowledge of QMS, including document control, training, CAPA, audits, change control, and nonconformance processes.
Experience supporting internal and external audits and maintaining compliance with regulatory and quality standards.
Familiarity with CAPA processes, root cause analysis tools, and continuous improvement methodologies.
Experience reviewing quality data, metrics, and KPIs to identify trends and support decision‑making.
Strong collaboration and communication skills with cross‑functional teams and stakeholders.
Preferred experience maintaining training records, training matrices, or learning management systems.
ASQ‑CQE, ISO 13485, or Lead Auditor certification is a plus.
Proficiency in Microsoft Office applications and quality documentation systems.
Hands‑on experience with eQMS platforms; experience in eQMS implementation or migration is a plus.
Experience with supplier qualification, ASL management, or supplier audits preferred.
Self‑motivated, able to manage multiple assignments simultaneously.
Strong organizational and problem‑solving skills.
Detail‑oriented.
PAVmed and its subsidiaries are committed to creating a diverse environment and are proud to be equal‑opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We are also committed to compliance with all fair employment practices regarding citizenship and immigration status.
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Compétences linguistiques
- English
Avis aux utilisateurs
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