Quality Control Supervisor

Role Purpose

This position coordinates product team support for receiving inspection, manufacturing operations, and the release of product.  Responsibilities include providing quality guidance, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities.

This position works closely with other functions within the organization (Manufacturing, PEx, Quality, Engineering, Procurement and Marketing) and is responsible for the quality of the product and process for the assigned product line(s). 

Description of Work

• This position directly supervises Quality team members across all production crews for the Durham manufacturing campus.
• Recruits, interviews, and selects hourly personnel, guides the development of employees through training programs, conducts quarterly performance appraisals, ensures associates attend mandatory training, and administers employee disciplinary action.
• Responsible for enforcing all plant policies and driving accountability for individual performance.
• Support the investigation of Corrective & Preventive Actions (CAPA), product non-conformances, and of customer complaints, providing solutions where possible.
• Develop and implement incoming inspection plans for raw materials.
• Support Continuous Improvement activities in cooperation with the Performance Excellence department (PEx).
• Develop/Revise Quality Plans including: incoming, in-process, and final inspection; provide training to those affected by the plans.
• Implement proven inspection and metrology improvements and associated training.
• Create / Revise technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO standards
• Serve as a resource for performing internal audits to ensure quality system compliance.
• Process incoming customer complaints, assist with complaint investigations, and provide documented feedback of corrective actions to the customers.
• Provide customer support through help desk ticket responses, including completion of requested technical questionnaires, and providing evidence of quality/ regulatory certification for the plant.

Long Description

Skills/Experience:

• Knowledge of the regulatory industry requirements such as ISO13485, ISO 15378, Quality Systems Regulation CFR 21 part 820, GDP / GMP-Good Doc / Good Manufacturing Practices.
• Capable of the integration and application of user aimed manufacturing process documentation while meeting business and regulatory requirements.
• Working knowledge of spreadsheet applications and word processing to perform necessary tasks for preparing required data analysis, reports, documents and general communication.
• Capable of prioritizing time to handle multiple assignments and to interact with product teams.
• Able to influence individuals without authority and to motivate others within a project team.
• Flexibility to lead project teams or be a team member.
• Able to make decisions regarding product disposition and corrective and preventive action effectiveness. Comfortable in giving direction to accomplish assigned tasks.
• Must be action oriented, capable of making informed decisions, be self-motivated, capable of influencing without authority.
• Ability to work independently and manage multiple priorities. Must be an effective communicator (written and verbal), highly organized, motivated, detail oriented with excellent analytical thinking and problem-solving skills.
• Flexibility to assume ownership on projects and coordinate the efforts of others to complete project goals. Or be on a team to support other project Leads; must also possess the ability to effectively manage conflict.
• Knowledge of manufacturing processes and relevant statistical methods for quality assurance preferred.

Experiences/Education - Required

• BS in Technical field (Engineering or Statistics preferred) or 4 years manufacturing environment leadership/supervisory responsibilities in absence of degree.
• Minimum of four (4) years of experience, preferably in a manufacturing environment with corresponding leadership or supervisory responsibilities.
• Knowledge of the regulatory industry requirements such as ISO13485, ISO 15378, Quality Systems Regulation CFR 21 part 820, GDP / GMP-Good Doc / Good Manufacturing Practices.