This job is closed
We regret to inform you that the job you were interested in has been closed. Although this specific position is no longer available, we encourage you to continue exploring other opportunities on our job board.
Global Design Control Leader
Solventum Konsult Ab - Maplewood, MN
posted about 2 months ago
About the position
The Global Design Control Leader at Solventum is responsible for overseeing and implementing the Global Design Control Process within the Quality organization. This role involves managing process updates in compliance with global regulations and standards, driving consistency in product launches, and elevating design control competence across the enterprise. The leader will also support audits and regulatory interactions, fostering a culture of compliance and process excellence to enhance healthcare outcomes.
Responsibilities
- Own and implement the Global Design Control Process.
- Manage process updates in alignment with global regulations and standards including ISO 13485:2016, 21CFR820, and EU MDR.
- Advance the Design Control Process to support Solventum's businesses while maintaining compliance.
- Drive consistency in execution towards robust product launches and efficient change management.
- Elevate competence in design control principles through effective global process deployment and coaching best practices.
- Support audits and interactions with regulatory agencies and notified bodies.
- Transform culture and passion around process and compliance to enable better, safer, smarter healthcare.
Requirements
- Bachelor's Degree or higher in an engineering, science, or quality discipline from an accredited institution.
- Twelve (12) years of combined experience in Medical Device, Pharmaceutical, or Combination Product experience with a Product Quality or Engineering focus.
- Five (5) years proven experience in quality management systems defining and deploying the design control process.
Nice-to-haves
- Master's degree in Quality Assurance / Management, Chemistry, Biology / Microbiology, Material Science, or related discipline from an accredited institution.
- 15+ years of combined experience in Medical Device, Pharmaceutical, or Combination Product experience with a Product Quality or Engineering focus.
- Demonstrated leadership in the application of design controls for new product development or major product redesign.
- Six Sigma experience and/or certification related to the design and manufacture of new Medical Device, Pharmaceutical, or Combination Products.
- Scientific knowledge and experience in development of medical devices and relevant regulations and standards applicable to medical device compliance.
Benefits
- Health savings account
- Disability insurance
- Relocation assistance
- Health insurance
- Dental insurance
- Flexible spending account
- Vision insurance
- Life insurance
- Retirement plan
