Design Controls Manager REMOTE

JobgetherJobgether·Remote(Anywhere in the World)·Work From Anywhere
Other
Excel

WFA Digital Insight

The demand for skilled design control specialists has surged, driven by the need for efficient product development and compliance with global regulatory standards. Jobgether's remote Design Controls Manager role stands out for its emphasis on driving process improvements and shaping the culture of compliance. Candidates with experience in quality systems and design controls will have an edge in this role, which requires strong leadership and communication skills.

Job Description

About the Role

The Design Controls Manager will collaborate closely with various departments to ensure compliance and efficiency in design control processes. This role drives improvements across product development processes, supporting timely product releases and adherence to global regulatory standards.

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.

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.

How to Stand Out

  • Develop a strong understanding of regulatory standards such as QSR, ISO 13485, and MDSAP to stand out in this role.
  • Showcase experience in leading design processes and process improvements in your application.
  • Prepare examples of successful collaborations with cross-functional teams to demonstrate your leadership skills.
  • Be ready to discuss your approach to ensuring conformity of processes and records to global regulatory standards.
  • Highlight your ability to communicate complex ideas effectively, both verbally and in writing.

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