Quality Assurance Supervisor

Summary of Role: Supervises, coordinates, and coaches employees responsible for customer complaints/issues, Quality Systems, Document Control, Incoming Quality Assurance, In-Process Inspection, and Product Release. Responsible for Quality System Activities that include adherence to ISO and FDA standards, project validations, and document control.

Day to Day Responsibilities:

• Supervises the daily activities of the Quality Department
• Develops, modifies, applies and maintains quality evaluation and control systems and protocols for processing materials into partially finished or finished materials product.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs and analyzes inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and resolve responsibility for, products or materials that do not meet required standards and specifications
• Support Supplier Quality Management program.
• Participates in the process of establishing plant metrics and targets.
• Coordinates and participates in customer audits and customer visits.
• Maintain the systems and actions necessary to ensure compliance with quality system and ISO registration.
• Disposition of Incoming Non-Conforming Materials, WIP, and Finished Goods.
• Participates in Management Review
• Employee hiring, development and performance management
• Assist employees in setting daily production priorities.
• Evaluate team and individual performance and delegate responsibility, authority, and accountability accordingly.
• Audits quality systems for deficiency identification and correction. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Participates in New Product/Process projects as well as internal improvements.

Required Education:

• 4-year degree the field of science including microbiology, chemistry, biology or related science fields

Required Experience:

• Supervisory experience
• Quality assurance experience
• Understanding of ISO 9001, FDA QSR and/or all required ANSI / AAMI / ISO or USP standards and regulatory requirements.

Required Skills:

• • Experience with investigations and root cause analysis.
  • Proficiency in Microsoft Word and Excel
  • Detail-oriented
  • Ability to lead small teams