Design Controls Manager REMOTE

Jobgether•Prior Lake, MN

2d•$99,300 - $198,700•Remote

About The Position

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Design Controls Manager - REMOTE. As a key player in ensuring compliance and efficiency in design control processes, you will collaborate closely with various departments including Regulatory, Quality, and R&D. Your expertise will be critical in driving improvements across product development processes, ensuring adherence to global regulatory standards while supporting timely product releases. This role not only influences product outcomes but also involves shaping the culture of compliance and excellence within the organization.

Requirements

BS in Management, Engineering, or Science preferred, or equivalent experience.
5+ years of Quality or R&D experience in a medical device company.
In-depth knowledge of Quality System Regulation (QSR), ISO 13485, and MDSAP.
Expertise in QMS subsystems including CAPA, audits, risk management, and design control.
Experience leading design processes in a medical device context.
Demonstrated leadership and ability to influence and communicate globally.
Strong written, verbal, and interpersonal communication skills.
Ability to work independently and collaboratively.
Willingness to travel 25% including international trips.

Responsibilities

Partner in optimizing and streamlining design control requirements for medical devices.
Lead process development and improvement projects with cross-functional teams globally.
Conduct and develop training on design controls and related process changes.
Ensure conformity of processes and records to global regulatory standards.
Audit design records to ensure compliance and address non-conformances.
Perform gap analyses against international regulatory standards and propose updates.
Maintain expertise in global design controls and related standards.
Mentor R&D and Quality Assurance teams to align with policies and procedures.
Participate in audits as a design controls expert and company representative.
Collaborate with R&D to ensure compliance in software tool implementations.