Role Summary: The position is responsible to develop, maintain and communicate the PI Quality Program that satisfies company goals. This program, including SPC, is then taught to production staff to be implemented in day-to-day production. This position reports to the Director of Quality and is responsible for staying aligned with the overall PI Quality direction.
Personality and Interest Profile - You may enjoy this role if you:- Have strong interpersonal skills, including written and oral communication skills
- Have experience working with, and presenting to, senior executives
- Have excellent communication and presentation skills; are comfortable interacting with customers related to specifications and quality issues.
Accountable for: - Evaluating overall effectiveness of the PI Quality Program, recommends revisions as needed and communicates with necessary department heads to ensure that the program meets or exceeds customer requirements.
- Being thoroughly versed in Statistical Process Control to train production staff to implement SPC at all production levels.
- Following good manufacturing practices to ensure product safety.
- Working closely with internal departments and Customers to arrive at acceptable part specifications and communicates these standards to all affected departments-specifically to production via check sheets.
- Providing direct supervision and training to Quality Inspectors/Technicians in the performance of routine or random inspections and maintenance of appropriate documentation of findings.
- Managing the Calibration program and schedule for the Cross Plains plant.
- Performing Root Cause Analysis for Customer Call Reports (CCRs).
- Interacting with customers for returned parts and coordinates rework or other appropriate action. Communicating resolution to necessary internal departments.
- Completing requirements from Corrective and Preventative Action Resolution (CPAR) Teams.
- Remaining current with new Quality Technology and recommends changes to Company Quality Program as needed.
- Assisting in the design, implementation, and continued maintenance of quality measures & registration.
- May serve as an SQF practitioner.
- May serve as a backup SQF practitioner for any other plant.
- May respond to customer audits.
- May serve as a member of the management team.
- Performs other duties as required.
Minimum Qualifications:- Bachelors' degree in Material Science or Engineering.
- ASQ CQE designation, or progress towards same, is required.
- Experience with Statistical Process Control and other statistical analysis tools.
Desired Qualifications: - Strong interpersonal, verbal, and written communication skills
- Medical packaging experience
- Experience in a manufacturing environment
- Desire for continual learning and personal development
- Product validation experience
- Formal, direct leadership experience
- Keeps commitments; exhibits candor and courage - is not afraid to establish a visible presence and point of view, to engage in spirited and constructive debate, to hold others accountable.
Physical Demands:- Frequent keyboard use/data entry
- Prolonged periods of seated work
- Prolonged periods of standing work
