Remote Design Controls Lead

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

WFA Digital Insight

The demand for skilled design control professionals has grown significantly in recent years, driven by the need for efficient and compliant product development processes. With the rise of remote work, companies like Jobgether are looking for talented individuals who can lead design control initiatives globally. To succeed in this role, candidates will need strong technical skills, excellent communication abilities, and experience working in a fast-paced environment.

Job Description

About the Role

The Design Controls Lead will play a critical role in ensuring compliance and efficiency in design control processes, collaborating closely with various departments including Regulatory, Quality, and R&D.

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

  • Develop a strong understanding of design control processes and global regulatory standards to stand out as a candidate.
  • Highlight your experience with quality management systems and audit processes in your application.
  • Be prepared to discuss your approach to leading cross-functional teams and driving process improvements.
  • Showcase your expertise in design control and quality systems through specific examples and case studies.
  • Familiarize yourself with the company's products and mission to demonstrate your enthusiasm and interest in the role.

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