Design Quality Principal Engineer required for leading Chemicals Company
- Design Quality Engineer
- Twin Cities, MN
A leading production company is seeking a Design Quality Principal Engineer to lead their ever-growing team. Do you have Healthcare, Pharma, or Medical Device experience? Are you a problem solver? If you answered yes to any of these questions, enjoy being part company with a steady path of evolution and are looking to take your career to the next level, then apply now!
Summary:
The Design Quality Principal Engineer will be responsible for ensuring compliance, facilitating audits, and continuous improvement. This role will partner with the R&D, Manufacturing, customers to lead the prototyping, and product/process development process. This position will also be responsible for implementing the site quality management system and keeping compliance with global regulatory requirements, and company practices and procedures.
Design Quality Principal Engineer will:
- Serve as the site Quality Management Representative for the site:
- Ensure site compliance with relevant requirements and guidelines
- Push continuous improvement of site procedures
- Facilitate external and internal audits as required
- Supervise a team of design quality engineers and deliver strategic leadership in the areas of product design, prototyping and process development:
- Oversee the management and preservation of Design History Files, Change Control Records, and Risk Management Files
- Supervise and escalate design control process non-conformities
- Trace design corrective actions and follow-up on accomplishment
- Offer Subject Matter Expertise in reference to design control, change control, and risk management regulatory conditions
- Apply measures to increase efficiency of design transfer to the manufacturing sites
Design Quality Principal Engineer should have the following skill set:
- Bachelor's degree in a scientific, technical, or in a business field
- Minimum 3 - 7 years of experience working in regulated quality systems
- Minimum 3+ years of experience in manufacturing, quality or R&D
- Familiarity with medical device manufacturing environments and quality systems