Government, Regulatory and Code, Quality Engineering
4 Year Degree
For over 40 years MPE- Inc. has been the leader in medical equipment and the electronic industry. Our products and services have kept pace with the rapidly changing technologies and industry needs. Our success is indicated by the rapid growth at our one location in Northwest Milwaukee.
The Director of Quality works closely with the other functional leaders in the Company including those in Finance, Engineering, Manufacturing, Business Development, Human Resources and Supply Chain. The Director of Quality is responsible for managing the quality function to our customer, ISO, FDA and other regulatory requirements.
This position reports directly to the CEO and is required to work onsite at our office in Milwaukee, WI
Serve as a key member of the Leadership Team that sets the Company’s strategic direction.
Ensure that our quality initiatives are aligned with the Company’s business goals, that we meet industry quality requirements and deliver quality products to our customers on a timely basis. Maintain, monitor and take appropriate action related to all customer feedback and the Early Warning Feedback System.
Participates in the reviewing of engineering designs to contribute quality assurance requirements and considerations.
Establish and implement quality procedures and specifications, inspection procedures and standards for raw materials, purchased components, in-process and finished products.
Develop and manage budgeting and budget execution within functional area with a focus on preventing quality problems and ensuring high standards for customer service.
Oversee all audits related to quality including coordination and execution of customer audits, external ISO audits, other regulatory quality audits (including FDA) and internal audits, initiating and implementing timely corrective actions as required. Investigate and evaluate additional ISO/FDA/Industry certification as warranted, and prepare for successful certification and maintenance of certification.
Develop training for and train employees on quality-related practices and system requirements.
Produce quality reports; analyze information, and address and resolve problem areas on a timely basis.
Develop and lead cross-functional teams to address and resolve quality issues and to improve levels of quality and on-time delivery.
Provide responsive technical assistance to external customers, internal customers and suppliers.
Conduct research on product defects and recommend timely modifications in product or quality standards where warranted.
Bachelor's of Science degree or combination of a Bachelor's and equivalent experience
Advanced degree strongly recommended.
10 years of experience in quality. Manufacturing, fabrication, or sheet metal preferred
Broad knowledge of Quality at the source and Lean manufacturing
Continuous improvement experience in a leadership role
Experience in ISO 9001 and ISO 13485 preferred
Experience low-volume, high product mix-manufacturing preferred
Experience in Quality management for medical devices or high-level electrical assembly preferred
Well-developed written and verbal communication skills for report writing, presentations, and interactions with diverse groups of people inside/outside of the corporation
MPE-Inc is an ISO-certified contract manufacturer specializing in medium volume production for medical and technology companies. Leveraging a vertically integrated business model, we take on the challenges that OEMs face by converting science to a scalable market-ready product of solution to accelerate time to market to drive revenue generation.