Description
Position Summary:- Responsible for implementing and maintaining the effectiveness of the audit and CAPA elements of the quality system.
- Ensures systems are established, effective and maintained in compliance with regulatory, corporate and site requirements and policies related to external and internal Audits and CAPA.
- Organizes, hosts and leads audit team for on site inspections and audits by customers, internal auditors, and regulatory agencies.
- Prepares audit responses and monitors and reports status of audit response progress to management.
- Develops annual internal audit plan and schedule. Leads and organizes scheduled and for cause internal audits. Issues internal audit report and monitors audit responses and effectiveness.
- Provides overall management of the CAPA process for the site. Leads the CAPA board.
- Identifies, leads and implements initiatives for the continual improvement of the CAPA and Audit processes.
- Develops, implements, monitors and maintains meaningful metrics to demonstrate the effectiveness of the Audit and CAPA processes.
- Report metrics and provide input to management reviews where Audit or CAPA issues are discussed advising management of potential risks and make recommendations.
- Thorough understanding of ISO/QSRs and the ability to apply the knowledge to the business to ensure compliance to the regulations.
- Travel is required - approximately 10-20%.
Minimum Requirements/Qualifications:
- B.A., B.S. or M.S. in Life Sciences or an engineering discipline or an equivalent combination of education, experience and/or licensure/certification.
- The required skills, knowledge and abilities that are typically acquired through a minimum of 3-8 years medical device experience in quality assurance.
- Knowledge of overall regulatory requirements associated with medical products into worldwide markets.
- Must have experience and knowledge of ISO 13485:2003, 21 CFR Part 820, IVD Directive and Canadian MDR.
- Communicate effectively both verbally and written with supplier and internal personnel in a professional manner. Strong writing and facilitation skills. Function with little to no supervision.
- Detail oriented and has the ability to lead multiple projects and activities assigned.
- Must have demonstrated hands on, results oriented, multi-tasking response to the urgent needs of the company and show a strong track record of meeting deadlines.
- CQA/ASQ/ISO Lead Auditor certification is preferred.
Physical Requirements:
- Normal office environment.
- Position may require frequent communication and walking to other areas in which designated PPE will be required.
- Position will require sitting and standing.
- Employee may occasionally lift and/or move up to 10 pounds.
This position has been approved for Relocation Assistance.
If this sounds like you then please send me your cv today or alternatively call in Real Staffing and ask for Andrew Murphy -