Lead Design Controls Manager (Remote)

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

WFA Digital Insight

The demand for skilled design control professionals in the medical device industry has seen significant growth, with companies like Jobgether seeking experts to drive compliance and efficiency. As the global regulatory landscape evolves, the need for leaders who can navigate these complexities is on the rise. With the shift towards remote work, this role stands out by offering flexibility and the opportunity to work with a diverse range of stakeholders, making it an attractive option for those looking to advance their careers in design control.

Job Description

About the Role

The Lead Design Controls Manager is a key player in ensuring compliance and efficiency in design control processes. This role involves collaborating closely with various departments, including Regulatory, Quality, and R&D, to drive improvements across product development processes and ensure 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.
  • Audit design records to ensure compliance and address non-conformances.

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

  • To stand out, highlight your experience with global regulatory standards and your ability to lead cross-functional teams.
  • Ensure your portfolio includes examples of process improvements and compliance audits you've led or been a part of.
  • Familiarize yourself with the latest trends in design control and quality management to show your commitment to ongoing learning.
  • When negotiating salary, consider the average market rate for similar positions in the medical device industry and be prepared to discuss your expectations based on your experience and qualifications.

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