Senior Quality Assurance Specialist
DeepHealth
full-time
Posted on:
Location Type: Remote
Location: Remote • South Carolina • 🇺🇸 United States
Visit company websiteSalary
💰 $130,000 - $145,000 per year
Job Level
Senior
About the role
- Actively engage cross-functionally within the organization, such as with the Engineering, Clinical and Marketing teams, to develop new products within the Product Lifecycle Management (PLM) and New Product Introduction (NPI) processes.
- Act as the Quality lead for design changes to existing DeepHealth products, including non-medical devices, to ensure compliance with the applicable standards and guidances.
- Guide junior Quality Assurance team members to ensure consistent implementation of Quality processes, including design control and risk management.
- Take ownership of product specific Quality Management System processes, such as CAPAs and complaint management, across the organization to ensure compliance and drive efficiency.
- Work cross-functionally to integrate products as a result of corporate and/or product acquisitions.
- Work as a team member with the Quality Assurance team to ensure compliance to US and OUS standards and regulations.
- Participate in the development of junior staff, as requested
- Collect/monitor quality metrics in support of Management Review
Requirements
- Bachelor’s degree in relevant field (or equivalent experience, i.e. Associate’s degree with 5 years of experience).
- Minimum of 8-10 working in a regulated industry (FDA and Software as a Medical Device preferred).
- Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
- Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62304 preferred.
- Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56, preferred but not required.
- Participation in regulatory audits a plus
- Excellent written and oral communication skills.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Management Systemdesign controlrisk managementCAPAscomplaint managementFDA Quality System RegulationsEU Medical Device RegulationISO13485ISO 14971IEC 62304
Soft skills
communicationteamworkleadershipmentoringcross-functional collaborationproblem-solvingorganizational skillsattention to detailefficiency improvementquality metrics monitoring