General Descriptions: Provide active management and oversight to the Quality Assurance function and employees to appropriately execute Quality Assurance systems and standards. Ensure that processes needed for the quality management system are established, implemented and maintained. Report to the president on the performance of the quality management system and any need for improvement. Promote and raise awareness of regulatory and customer requirements throughout the organization.

Key Duties/Responsibilities:

• Establish and monitor QA departmental goals and objectives.
• Manage and maintain:
  • Quality Manual
  • Document Control
  • Corrective and Preventative Action System
  • ISO Certifications
  • Calibration records
  • Non-conformance System
• Act as Management Representative for QMS responsibilities.
• Develop key metrics and reports to monitor the effectiveness of quality systems and recommend improvements.
• Work with Engineering to provide resources for new product development activity.
• Manage or conduct annual internal audits, supplier audits, or audits conducted by our customers as required.
• Manage and conduct periodic Quality Systems Management Reviews
• Proposed technical/processes/equipment modifications to ensure continuous improvement of product/process.
• Manage, mentor and coach QA and Lab staff and help them develop their skills and abilities for team effectiveness.

Additional Expectations, Skills and Abilities:

• Ability to: Achieve and Excel with Kindliness
• Regularly attend and participate in weekly Production and Steering Committee Meetings and monthly Communications meetings.
• Escalate concerns or issues to the President or Steering Committee as appropriate.

Prerequisite Qualifications:

• Bachelors’ degree in Quality, Engineering, Industrial Management or a related field or an equivalent combination of education and experience.
• Thorough understanding of quality assurance procedures, practices and inspection procedures.
• Experience with ISO 9001 and ISO 13485
• Minimum of 10 years in Quality Assurance, at least 4 of which should be in a leadership role in a manufacturing environment.
• Successful experience leading/directing a team
• Proficient in MS Office applications including MS Word and MS Excel.
• Experience with ERP and Document Control systems.
• Excellent organizational, verbal and written communication skills
• Deadline driven and results oriented.