The primary purpose of this job is to coordinate activities and provide daily direction to a significant size or volume of quality technicians and other team members to ensure that quality requirements, performance goals and improvement objectives are achieved. In addition, this role will develop process improvements and identify deficiencies in processes or systems that enable the department to execute at a more accurate and efficient level. Additionally, this role will work with production to ensure that efforts are aligned and will manage the day-to-day processes around performance management and attendance for each individual in the department.
- Adheres to Integer Core Values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
- Manage daily performance and attendance of Quality Assurance Technicians in the inspection and final release of sub-component parts and finished goods. Provide work direction and guidance throughout the shift on issues relating to Quality and schedule attainment.
- Review all product non-conformances and determine necessary corrective actions.
- Monitor/track QA/QC department metrics and develop continuous improvement plans that drive site Gs&Os.
- Oversee incoming/in-process sub-components and finished goods.
- Support Quality Engineering and Manufacturing Engineering in the resolution of non-conforming materials.
- Supervises Associates in a manner that fosters a safe work environment and self-directed team approach.
- Promotes an atmosphere of diversity, open communication and trust, affording opportunities for training and growth.
- Identifies, arranges and/or provides training to ensure a safe, efficient, quality work environment with focus on continuous improvement through Lean manufacturing principles.
- Facilitates communication, coordination and conflict resolution within and among work groups.
- Provides leadership to Associates in all areas including: hiring, performance management, coaching, counseling, and corrective actions.
- Performs other functions as required.
Bachelors in a related field.
At least 3-5 years of prior QA/QC Supervisory experience in a manufacturing environment preferred; medical device experience preferred.
ISO 1345, FDA 21 CFR Part 820 and other FDA requirements. Good Manufacturing Practices, Good Documentation Practices. Auditing training and experience preferred.
Geometric dimensioning and tolerancing (GD&T), gauging, and inspection methods.