Director of Operations - Quality chez None

Minnetronix provides award-winning product design, development and manufacturing services to the medical device and life science marketplaces. Minnetronix successfully incorporates custom electronic, mechanical and software engineering into finished Class II & III devices and systems such as cardiovascular and monitoring systems, therapeutic and implantable devices, and diagnostic instruments.  Minnetronix is ISO 13485 certified and is an FDA registered manufacturer.

Job Summary:

This position is responsible for leading the Operations Quality organization; and as such provides leadership, management, and career development for personnel within the group. The Director is a member of the functional management team.  Responsibilities will be of both a strategic and operational nature to drive the company’s short- and long-term initiatives.

Essential Duties and Responsibilities:

1. Provide leadership and direction to ensure that the products manufactured meet regulatory requirements and the expectations of Minnetronix and the customer.
2. Manage manufacturing QA staff working on cross functional teams supporting the manufacturing of complex electronic based medical devices, including career development, individual & team goals and performance reviews.
3. Collaborate with Manufacturing and Supply Chain Functional Managers to drive operational improvements to improve the competitive position of the company by developing or improving strategically important processes, technologies and/or products for existing and future businesses.
4. Maintain and ensure compliance of Minnetronix’ quality management system to regulatory requirements including, but not limited to, Quality Systems Regulations 21 CFR 820, ISO 13485
5. Prioritize and balance short-term needs with long-term strategic initiatives.
6. Manage and oversee all non-conformances and company (including sub-contract manufacturing) related CAPAs ensuring root cause analysis, corrective and preventive actions and final dispositions are performed in a timely and compliant manner.
7. Measure and report appropriate quality metrics and trending.  Perform analytical, statistical and trending analyses on complaint data to support timely review and proactive response or corrective action.
8. Support the internal audit program ensuring procedures are adhered to and updated to reflect the business needs.
9. Serve as change agent to drive a continuous improvement culture that builds quality in and identifies and mitigates risk, focusing on preventive action.
10. Together with HR, recruit, retain and develop top technical talent.

Qualifications:

1. Proven track record of leadership of a quality or manufacturing support organization.
2. Bachelor’s degree, preferably in a scientific or engineering discipline; an advanced degree in management is also desirable
3. Minimum 10 years’ experience in manufacturing/quality operations
   • Including manufacturing of electro-mechanical product.
   • Including regulated industry experience (aerospace, medical, etc)
   • Experience in Services business and/or CDMO a plus
4. Ability to assess conflicting input from many sources and formulate a solution that meets technical and business needs.
5. Demonstrated leadership behaviors including effective communication, critical thinking and decision making, coaching and mentoring, and promoting a strong sense of urgency.
6. Demonstrated willingness and ability to effectively challenge the status quo.
7. Experience with Design for Six Sigma, Design for Test, Design for Manufacturability and Reliability preferred.
8. Strong communication and negotiation skills in formal and informal settings

Leaders are encouraged to be creative and innovative, while at the same time are expected to learn, improve and champion our structured processes. In addition, these leaders are expected to contribute to our team while enhancing their own management expertise and increasing their responsibilities.

Must be authorized to work in the United States.

EOE / AA Employer