Senior Quality Systems Engineer
Medtronic
full-time
Posted on:
Location Type: Office
Location: Galway • 🇮🇪 Ireland
Visit company websiteJob Level
Senior
About the role
- Manage and drive the Corrective and Preventive Action (CAPA) Program.
- Including ownership of the investigations, Root Cause Analysis and resulting Corrective and Preventive Actions, and developing sound effectiveness check plans.
- Communication of CAPA status and escalation to applicable stakeholders, both internal and external.
- Executing of Health Hazard Analysis (Product Risk Assessments)
- Provides oversight into the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Provides technical expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Supports internal and external audits and inspections.
- Managing and driving audit and inspection finding investigations and resolutions with a cross-functional team.
- Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
Requirements
- Requires a Level 8 degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
- Experience in the Medical Device Industry or a similar role
- CAPA ownership/execution experience, required
- Strong understanding of medical device regulatory and governmental regulations (EU MDR, FDA, MDSAP, ISO 13485, etc.)
- Experience in Risk Management
- ISO 14971
- Medical Device Auditing Experience
- Project Management experience
- Strong analytical and problem-solving skills
- Excellent communication skills
- Excellent writing and editing skills
- Computer skills in the English language.
- Ability to work effectively independently, within teams, and across functions.
- Ability to travel within Ireland and Internationally on occasion.
Benefits
- Competitive salary
- Flexible Benefits Package
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
CAPA ownershipRoot Cause AnalysisHealth Hazard AnalysisRisk ManagementISO 13485ISO 14971Medical Device AuditingProject ManagementRegulatory complianceQuality programs
Soft skills
analytical skillsproblem-solving skillscommunication skillswriting skillsediting skillsteamworkindependencecross-functional collaboration