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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Compliance and Quality Management Systems, with a strong focus on internal and external audit processes, regulatory requirements, and continuous improvement initiatives. Proficient in analyzing quality metrics and supporting CAPA management within regulated industries.
Highest-signal resume keywords
Quality ComplianceInternal AuditsQuality Management SystemsISO 13485Certified Internal Auditor
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 AssuranceQuality SystemsRegulatory InspectionsCAPA ManagementQuality Risk ManagementDocument ControlChange ManagementQuality ReportingQuality Metrics AnalysisManagement Review Preparation
Soft Skills
CollaborationCommunicationProblem-SolvingLeadershipCultural Promotion of Quality
Certifications & Qualifications
Certified Internal Auditor
Industry Keywords
Medical DevicesPharmaceuticalBiotechnologyRegulated IndustryFDA QSRMDREMEALife SciencesEngineeringQuality Management
About the role
Key responsibilities & impact- Coordinate and execute the regional Quality Compliance program across EMEA
- Develop and maintain the annual EMEA internal audit program based on risk, regulatory requirements, and business priorities
- Plan, conduct, document, and report internal audits across EMEA locations and functions
- Monitor audit findings and support site management with timely implementation and closure of CAPAs
- Coordinate and support notified body, certification body, customer, and regulatory audits and inspections
- Prepare and consolidate Management Review inputs and reports
- Analyze quality metrics and trends to support Management Review discussions and decision-making
- Support maintenance and continuous improvement of the Quality Management System
- Provide guidance on quality compliance requirements, audit readiness, and best practices
- Support CAPA management, quality risk management, document control, change management, training compliance, and quality reporting
- Collaborate with regional and global Quality teams to align compliance initiatives and quality objectives
- Promote a culture of quality, compliance, and continuous improvement
Requirements
What you’ll need- Bachelor's degree in Life Sciences, Engineering, Quality Management, or a related discipline
- Minimum 3–5 years of experience in Quality Assurance, Quality Compliance, or Quality Systems within a regulated industry
- Experience in Medical Devices, Pharmaceutical, Biotechnology, or similar regulated industries
- Experience planning and conducting internal audits
- Experience supporting external audits and regulatory inspections
- Experience preparing management review materials and analyzing quality metrics
- Strong knowledge of Quality Management Systems and applicable regulations and standards, including ISO 13485, FDA QSR, and MDR or equivalent
- Certified Internal Auditor qualification preferred
- Fluent in English; additional European languages are an advantage
- Ability to travel within the EMEA region as required
Benefits
Comp & perks- Comprehensive Total Rewards program
- Reward and recognition opportunities
- Competitive compensation and benefits programs
- Learning, growth, and development opportunities
- Face-to-face collaboration culture supporting learning, progress, and success