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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management Systems (QMS) and regulatory compliance, including MDSAP, MDR, and ISO 13485. Proven ability to lead continuous improvement initiatives and manage quality assurance and regulatory affairs in the medical device industry.
Highest-signal resume keywords
Quality Management System (QMS)Regulatory Compliance (MDSAP, MDR, ISO 13485)Risk AssessmentContinuous ImprovementAuditing Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality System Development (QSD)CAPA Process ManagementTechnical File DevelopmentClinical EvaluationPost-Market Surveillance
Soft Skills
Strong Organizational SkillsInterpersonal CommunicationProblem-Solving SkillsAttention to DetailCoaching and Mentoring
Tools & Technologies
Cloud Computing
Industry Keywords
FDA GuidanceMedical Device ComplianceInternal AuditsSupplier AuditsEuropean Conformity (CE)
Tech Stack
Tools & technologiesCloud
About the role
Key responsibilities & impact- Lead continuous improvement initiatives across AirStrip’s Quality Management System
- Ensure compliance with global regulatory standards, including MDSAP, MDR, UKCA, ISO 13485, and QMSR
- Develop, implement, and maintain QSDs for compliance with the Company’s Quality System, 21 CFR Part 820, and FDA guidance related to SaMDs
- Participate in audits conducted by Notified and Regulatory bodies
- Support New Product Development and Existing Product Enhancement teams throughout development of DHFs, Technical Files, Risk Management, Clinical Evaluation, and Post-Market Surveillance Files
- Participate in Nonconforming Product and Complaint Processes
- Resolve systemic product non-conformances through the CAPA Process
- Ensure timely Internal and Supplier Audits
- Organize and coordinate CAPA, Complaints, Clinical Evaluation, and Post-Market Surveillance data for Management Review meetings
- Maintain international authorizations and registrations, including ISO 13485:2016, MDSAP, MDD/MDR, UKCA, and CMDCAS
- Establish a compliance knowledge base for compliance statistics and current regulations
- Build expertise on topics such as cloud computing
- Directly supervise the QA/RA Associate Project Manager
- Implement proactive compliance decisions, including European Conformity (CE) requirements
- Upgrade processes to meet MDR requirements
- Maintain regulatory and quality compliance for AirStrip solutions in designated markets
- Participate in responses to Enterprise User compliance questionnaires
- Ensure corporate SOPs comply with FDA, CE, MDSAP, ISO, DIACAP, and general quality principles
Requirements
What you’ll need- Bachelor's degree in Healthcare, IT, Quality, or related field; commensurate experience will be considered in lieu of degree
- Minimum 5 years of experience managing QA / RA in a medical device company
- Minimum 5 years of experience understanding guidance from FDA and international regulatory agencies
- Strong organizational, planning, and follow-up skills
- Strong interpersonal communication (written and verbal)
- Effective problem-solving skills; results-oriented
- Outstanding attention to detail
- Creative and innovative thinker
- Coaching and mentoring for direct reports
- Continuous improvement for QMS
- Proven compliance with standards and regulations such as MDSAP, MDR, UKCA, ISO 13485, and QMSR
- Strong understanding of risk assessment
Benefits
Comp & perks- Bonus potential
- Remote work arrangement
- Up to 30% travel to company office locations and client sites as needed