What will you do
Performs Quality Assurance tasks, including management of the CAPA process and Internal audit process. Ensures compliance to the Integrated Management System and to all applicable regulatory standards and directives.
Facilitates the internal audit program, including preparation and maintenance of Internal Quality Audit schedule. Performs internal quality audits.
Facilitate the CAPA program, including CAPA Review Board activities and preparation of KPI reports.
Assures overall compliance and reporting of the Internal Quality Audit and CAPA programs are documented and made available in a timely manner.
Assures product quality trends and audit observations are documented and escalated in accordance with the formal Corrective and Preventative Action process.
Supports all third-party inspections and audits (NB, FDA, etc.) according to the Audit Readiness Program.
Communicates significant issues or developments identified via Internal Audit and CAPA programs to management. Prepares periodic KPI reports and as an input into Management reviews.
Actively participates in Continuous Improvement Projects
Maintains a working knowledge of government and industry quality assurance codes and standards.
Maintains compliance and continuously improves the Quality Management System (QMS) in regards to ISO 9001, ISO 13485, ISO 14001 and CFR 21 and further regulatory requirements which apply to a medical device manufacturer.Who you are
Bachelor's Degree (in a technical discipline preferred), or the equivalent in education, training and experience.
- 3-5 years of medical device product experience related product development and Quality System Management.
- Strong working knowledge of risk management and design controls for medical device products.
- Skilled in test plan development and root cause failure analysis
- Working knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 9001, ISO 13485, MDR
- Effective written, verbal and presentations skills
- Strong influencing and negotiation skills at all levels
- Good communication and leadership skills
- Experience utilizing standard root cause analysis tools (5-WHY, FTS, fishbone diagrams, etc.)
- Certified Quality Auditor Preferred
- Experience using electronic quality management systems software systems
Internal code #LI-MC1 MON