Quality Systems Supervisor

Role Purpose

Assist with the management of quality system-related processes, including Corrective and Preventive Actions (CAPA), complaints, document control, and change management. Manages internal audit program as well as conducts internal audits to measure and assure adherence to established QA standards for system performance.  Collaborate closely with internal departments to ensure quality is maintained throughout the entire product lifecycle. Lead and support customer audits. Develop and maintain comprehensive documentation of all quality systems and procedures in accordance with relevant ISO standards / FDA regulations. Provide training and support to the quality assurance team on systems, policies, procedures, and core processes. Develop strategies to improve efficiency, profitability, and quality.

Audits quality systems for deficiency identification and correction. Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements. Receives assignments in the form of objectives with goals and process to meet goals outlined. Provides direction to employees according to established policies and management guidance. Work is reviewed by management to measure meeting of objectives. Administers company policies that directly affect employees. Recommends changes to unit or sub-unit policies. Frequently interacts with supervisors, outside customers, and functional peer groups at management levels. Interaction normally requires the ability to gain cooperation of others.

Supervises, coordinates, and coaches’ direct reports. Responsible for Quality System Activities that include adherence to ISO and FDA standards, project validations, and document control.  Responsible for the release of product, and quality record management. Responsible for trending effectiveness of Quality Management System Processes.

Key Responsibilities

• Supervises the daily activities of the Quality Assurance Specialist, Document Control, Product Compliance Coordinator, Training Coordinator, Customer Support specialist , contingent workers, etc.
• Attends complaints team meetings, as required, to review customer complaint information for trends and recommends improvements.
• May complete customer questionnaires.
• May interface with Scientific Support relating to customer questions.
• Oversee site-level Supplier Quality Management program and works directly with Division Supplier Quality to ensure compliance.
• Participates in the process of establishing plant metrics and targets.
• Manages the product certification program.
• Develops positive working relationships using effective interpersonal skills and networking within the plant across departments.
• Counsel direct reports by providing formal and informal performance feedback.
• Maintain and enforce all safety regulations and housekeeping standards on a consistent basis.
• Interpret and enforce Plant and company policies and procedures on a consistent basis.
• Coordinates and participates in customer audits and customer visits.
• Maintain the systems and actions necessary to ensure compliance with the Kennebunk quality system and ISO registration.
• Ensure cooperation with Engineering in the implementation and evaluation of new processes or equipment.
• Support disposition of Incoming Non-Conforming Materials, WIP, and Finished Goods.
• Participates in Management Review
• Employee development and performance management
• Evaluate team and individual performance and delegate responsibility, authority, and accountability accordingly.
• Evaluate temporary deviation requests and product / process changes.

Experiences/Education - Required

• Minimum of a 4-year degree in the biological sciences (preferred), or engineering 
• A minimum of 3 years of Quality Assurance / Quality Systems experience, preferably in an ISO 13485 environment
• A minimum of 2 years of experience in a supervisory or leadership position
• Strong knowledge of Quality Systems regulations (ISO 13485, FDA 21 CFR part 820, ISO 11137, ISO 14644)
• Familiarity with Quality Control concepts and test methods
• Proficiency in Microsoft Word and Excel
• Must be detail-oriented
• Able to work well both independently and in a group setting