Summary, Responsible to the Plant QA Manager for the management of the plant documentation system, internal audits, corrective/preventive actions, diagnosis of chronic quality problems and quality trend analysis. Supports the plant in the identification and resolution of quality assurance and regulatory issues related to product lines to assure compliance with FDA regulations, ISO standards, Corporate directives and Company strategies.
Minimal travel is required with this position.
- The essential functions of this position include but are not limited to:
- Develop and maintain a system to define, track and trend all quality metrics (e.g. Complaints, Notifications, CAPA’s, Audits, etc.)
- Develop and implement improvement plans around quality and efficiency based on the outputs of quality performance metrics.
- Serves as the regulatory compliance coordinator for the plant. Meets and escorts Federal regulatory agency inspectors, such as: FDA and ISO.
- Be familiar with the products manufactured as well as the manufacturing process to assure compliance to Federal Regulations and International Standards as required.
- Manages the plant's internal audit program, and corrective/preventive action system to ensure compliance with Federal Regulations and International Standards where appropriate. Assists the QA Manager in all external audits of Broken Bow.
- Assists Quality Assurance personnel in addressing quality issues as appropriate.
- Works with other departments to maintain the highest quality standards.
- Responsible for the activities and programs as defined for this position in the Quality.
- Systems Policy Manual.
- Directs attention to the career pathing and development of all direct reports while working to develop technical expertise and managerial/supervisory competency.
- Manages the plant training program
- Bachelor's Degree required
- Minimum of 3 years working in a quality role within a manufacturing environment.
- Minimum of 2 years of supervisory experience required.
- Must have experience working within a regulated industry.
- Previous auditing experience required.
- CAPA and root cause analysis experience required.
Base Salary - $91,700 to $150,000
5+ to 7 years experience
Seniority Level - Mid-Senior
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
Must have manufacturing experiecne and previous compliance manager role.
Must have auditing and CAPA
Must have designed training programs