The Quality Manager will be based in Tempe, AZ. The Quality Manager will develop, implement and coordinate product assurance programs to prevent or eliminate defects in new or existing products. Will also be responsible to implement from zero the certification of ISO 13485 (Medical Quality System) taking as a base the Corporate Quality system by adjusting as per the internal requirements for a new molding business.
We are looking for someone who demonstrates:
- Intense collaboration
- Passionate customer focus
- Thoughtful, fast, disciplined execution
- Tenacious commitment to continuous improvement
- Relentless drive to win
Here is a glimpse of what you’ll do:
- Analyzes, evaluates and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends and design and development of new products for consideration by other members of management team.
- Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities.
- Cooperates with other top management personnel in formulating and establishing company policies, operating procedures and goals.
- Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements and operational procedures within program.
- Evaluates contents of reports from product assurance program department heads and confers with top management personnel preparatory to formulating fiscal budget for product assurance program.
- Conducts management meetings with product assurance program department heads to establish, delineate and review program organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives.
- Interface with customers on technical/quality issues and improvement initiatives.
- Responsible for managing customer audits and regulatory/compliance agency audits.)
Here is some of what you’ll need (required):
- BA Degree in Engineering or related field
- 8 years’ experience in Quality of Plastic Molding
- Medical Devise Experience and Clean Room Environment in the Molding Industry
- Experience in Quality Audits (recommendable on FDA Audits, mandatory ISO 13485)
Here are a few of our preferred experiences:
- Strong experience in Medical and Clean room environment
- An American Society for (ASQ) Certified Quality Engineers certification