- To oversee Quality Management activities globally, ensuring corporate compliance with internal processes/procedures, regulatory authorities, medical device standards and industry expectations. To ensure adequate quality monitoring procedures are implemented to proactively identify and resolve quality issues.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Serves as the Executive Management appointed Head of Quality Management whose responsibilities include the establishment, implementation, and maintenance of the Quality Management System in accordance with ISO standards.
- Develop and manage corporate Quality Management program to assure compliance of the company’s business processes with respect to applicable regulatory requirements (specifically GxP, 21 CFR Part 11, ECG, ePRO data collection standards, ISO standards, and medical device regulations).
- Management of the Acceptance Validation team. This includes responsibility for the development of Test Strategies, Master Plans, Acceptance Validation Protocols and creation of test scripts and associated datasets. The organization and oversight of test execution and deviation reporting and responsibility for the generation and distribution of Acceptance Validation Summary reports for the company’s core technologies.
- Management of the Training Coordination team. This includes responsibility for managing employee training programs, employee training files and related documentation for the organization. Assisting with the development and managing the implementation of Competency Requirements Documents (CRDs).
- Serve as the Official Correspondent & Owner/Operator for the company’s medical device management and registration with U.S. Food & Drug Administration.
- Serve as the primary contact in the preparation, conduct and follow up of Sponsor and domestic and foreign Regulatory Agency audits.
- Manage and perform corporate audits and assist in all corporate functions.
- Define annual audit schedules and oversee the conduct of ongoing audits of the following to assess compliance with the company’s SOPs, Sponsor requirements, and regulatory authorities.
- ISO Standards
- Internal processes (GxP)
- Project specific processes/requirements
- Computer Systems
- Review all Audit Plans and Audit Report. Maintain the status of all audit findings in the Quality Management database and ensure prompt resolution.
- Perform tracking/trending analysis of audit findings and assist operations in the implementation of corrective action plans, as appropriate.
- Supervise Technical Quality staff in the development, distribution, and tracking of monthly, and quarterly statistical analysis and reporting of CSS/Cardiology Inter/Intra Variability programs.
- Develop and ensure maintenance/management of the following quality documents:
- Quality Management System Documentation (Quality Manual, Local Quality Requirements)
- Corporate Policies
- Standard Operating Procedures
- External, Internal, Vendor Audit Database (Quality Management database)
- Annual Audit Schedules
- Perform the Quality Management review for all SOPs as well as manage the annual SOP review and update process through the controlled document management application.
QUALIFICATIONS AND SKILLS NEEDED: (Key wording should include if degree is needed, any travel requirements, special qualifications needed, skills, etc.)
- Bachelors Degree required.
- Minimum 5-7 years Management/Supervisory experience.
- 10-15 years Quality Management experience (QA/RA).
- Knowledge of GxP Standards, ISO Standards and applicable regulatory authorities
- Excellent organizational and communication skills
- Detail oriented
- Excellent computer skills including database management/design and proficiency in Microsoft Office Suite.