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Medical Device Quality Assurance
1 month ago
Quality Management Systems Specialist
Onsite
Must-Have Skills
- Exp with SAMD – Software as medical device
- Exp with Medial device QA system
- Technical writing – for QA documentation / SOP’s
Responsibilities:
- This subject matter expert will work cross functionally in a tech company
- The ideal candidate will act as the leader for the growing Medical Devices QMS team, draft SOPs, technical documents and have deep domain experience in digital health and software as a medical device (SaMD).
- Leverage operational experience to meet quality and regulatory goals, define processes within a medical device product area residing within a larger consumer electronics division
- Establish processes and deliverables for medical device product development programs per the FDA and ISO requirements for electromechanical and SaMD products
- Collaborate with systems and software engineering and other product development teams in establishing standard operating procedures for the definition of design history file (DHF) and device master record (DMR) deliverables
- Guide medical device development teams in their execution strategy for Design and Risk SOPs, review, approve, and audit DHF elements (e.g., plans, requirements, specifications, test protocols, test results, design traceability, risk management documents, design reviews, reports)
Qualifications:
- Bachelor’s Degree in Technical Science, min MS degree in quality assurance or equivalent
- 10 years of work experience in a highly regulated industry (e.g., Medical Devices, Bioengineering, Pharma, LifeSciences, Quality and/or Development)
- Experience in the application of ISO 13485, ISO 14971, 21 CFR 820 and other US regulations, IEC 62304, IEC 60601-1, MDD & EU MDR
- Experience authoring technical reports, business correspondence and standard operating procedures
- Proven communication skills
- Experience presenting clearly and persuasively to technical and non-technical audience
Full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
