Leads and provides strategic direction to the Waco Site for Quality Assurance. Ensures full compliance of Regulatory Agency requirements for raw materials, components and finished goods manufactured in the facility. The incumbent is also responsible for a team of quality engineers who provide quality oversight for compliance and continuous improvement. Ensures that all Quality assurance aspects for the site and associated activities are performed within budget, regulatory guidelines and the established timelines. Leads Quality Assurance teams including Batch Disposition team, Quality on the production floor, and batch issuance.
This position is responsible for the following:
- Maintaining a program to comply with the requirements of the FDA, EU and ISO 13485 - Medical Devices, and other relevant regulatory bodies for the site.
- Oversee investigation and implementation team activities; analyzing non-conformances for trends; and ensuring that all non-conformances are closed out in a timely manner with effective corrective actions.
- Work closely with the Waco Senior Staff to facilitate the effectiveness of Corrective Action Process on the shop floor.
- Manage the development of the QA staff.
- Assists with Corporate Vendor audits and supports corporate global projects as necessary.
- Responsible for implementation of new or changing regulations (FDA and worldwide) and GMP trends relevant to our facility and dissemination of this information on a plant wide basis.
- Responsible for the QA support of FDA or other regulatory inspections.
Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.
Regulated Responsibilities (including cGMP and EHS)
Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
Education and Experience:
Essential Knowledge, Skills & Abilities:
- A Six Sigma Black belt or Master Black belt certification is beneficial, but not required.
Significant Work Activities: N/A
Job Type: Experienced