Job Function Summary:
To oversee all Quality Control functions at incoming, in-process, and final inspection phases to ensure business objectives are achieved. Manage, develop and train QC Technicians in a multi-shift GMP operation.
- Management and development of Quality Control department, consisting of 30+ employees across three shifts.
- Ensures proper resourcing of Quality Control department including equipment and personnel.
- Accountable for all business objectives and goals and quality performance metrics in compliance with company and regulatory standards.
- Define and implement training programs to ensure all technicians understand and comply with quality standards for all products.
- Utilize Lean, and 5S methodology to develop process and programs to realize efficiencies, effectiveness and cost savings.
- Assists in initiating NCRs and coordinating Material Review Boards to determine final disposition as needed.
- Assists with confirming sterility release and the disposition of quarantined product.
- Maintains Quality Control DHRs for all product lines.
- Provides input for QC inspection techniques to assist in establishing efficient and effective methods for evaluating component parts.
- Reviews and Approves Engineering Change Orders / pilot shop orders / rework procedures as needed.
- Ensures proper execution and release of holds, including ship holds.
- Contributes to team effort by accomplishing related duties as requested.
Required Knowledge, Skills and Abilities:
- Demonstrated leadership, people development and team building skills.
- Strong interpersonal and communication skills with creative problem solving ability.
- Requires prior management experience.
- Inspection and measurement experience is preferred.
- Proficient in Microsoft Office applications (Word, Excel, PowerPoint).
- Experience working in a highly matrixed, GMP manufacturing setting.
- Knowledge of Lean, 5S or Six Sigma, with demonstrated results in cost savings and increased efficiencies.
- Bachelor's degree or equivalent work experience.
- A minimum of seven years of management experience in medical device or pharmaceutical manufacturing is required.