Design Controls Manager - REMOTE

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

WFA Digital Insight

As the demand for skilled professionals in medical device companies grows, design control expertise is becoming increasingly crucial. With 5+ years of experience in Quality or R&D, candidates can leverage their knowledge of global regulatory standards to drive improvements in product development. Jobgether stands out for its commitment to shaping a culture of compliance and excellence.

Job Description

About the Role

The Design Controls Manager is responsible for ensuring compliance and efficiency in design control processes. This involves collaborating closely with various departments, including Regulatory, Quality, and R&D, to drive improvements across product development processes and support timely product releases.

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.

How to Stand Out

  • Be prepared to provide specific examples of your experience with design control processes and global regulatory standards.
  • Showcase your ability to lead cross-functional teams and drive process improvements.
  • Familiarize yourself with Jobgether's products and services to demonstrate your understanding of the company's needs.
  • Highlight your expertise in QMS subsystems, including CAPA, audits, and risk management.
  • Use your cover letter to explain how your skills and experience align with the company's goals and values.

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