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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 and Regulatory Compliance within the medical device industry, ensuring adherence to international standards and effective complaint handling. Proficient in developing corrective action plans and maintaining compliance through training and documentation.
Highest-signal resume keywords
Quality Management SystemsRegulatory ComplianceISO 9001ISO 13485FDA CFR 21 Part 820
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 CAPAsNCRsSOPsWIsComplaint Device HandlingSAPWindchill Document ControlsGMPAuditingContinuous Improvement
Soft Skills
CommunicationProblem-SolvingCollaborationTrainingOnboarding
Tools & Technologies
LMS Training ToolComplaint-Handling Database
Industry Keywords
Medical DeviceRegulated IndustryNotified BodiesCompetent AuthoritiesEuropean Regulations
About the role
Key responsibilities & impact- Support business and site-level aspects of the quality management system for the Philips Image Guided Therapy Devices business.
- Support sites with continuous maintenance and improvement of the Quality Management System and its subsystems.
- Assist the Quality Manager as auditee for internal and external audits.
- Own and approve Quality CAPAs and facilitate/approve NCRs.
- Assist the EC MDD Authorized Representative with mandatory vigilance reporting and FSCAs to Notified Bodies, Competent Authorities, and customers within the EU.
- Implement and maintain the Quality Management System according to European and international regulations and guidelines.
- Update and write SOPs and WIs to ensure compliance with standards.
- Approve QMS changes in lieu of the Quality Manager.
- Maintain QMS documents and records for operational and commercial processes, including field sales, Customer Service, and Order Management.
- Ensure timely and orderly Complaint Device Handling.
- Maintain the complaint-handling database and SAP searches to support complaint investigations.
- Support Quality and Operations teams with process implementation, including system installations.
- Support Operations with physical product distribution and logistics.
- Maintain the LMS Training tool for International operations.
- Assist with onboarding processes for new hires.
- Support and sometimes execute change notices in Windchill Document Controls.
- Escalate non-compliance, risks, and improvement opportunities to Management and develop corrective action plans.
- Identify and investigate potential trends for improvement initiatives.
- Maintain employee compliance through training sessions.
Requirements
What you’ll need- Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
- 5+ years of experience in Quality Management Systems, Regulatory Compliance, and Auditing with medical device or a regulated industry (preferred).
- Proficiency in ISO 9001, ISO 13485, FDA CFR 21 Part 820, and Good Manufacturing Practices (GMP).
- Fluent in English; any other language is an advantage.
Benefits
Comp & perks- 3% bonus linked to KPIs and company results