Design Controls Leader (Remote)

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

WFA Digital Insight

As demand for skilled professionals in regulatory compliance grows, the Design Controls Leader role stands out in the current remote job market. With expertise in global design controls and quality system regulation, candidates can shape the culture of compliance within organizations. Jobgether's commitment to excellence makes this a unique opportunity for those who thrive in fast-paced environments, where attention to detail and leadership skills are highly valued.

Job Description

About the Role

The Design Controls Leader will play a crucial role in ensuring compliance and efficiency in design control processes, collaborating closely with Regulatory, Quality, and R&D departments. This position influences product outcomes and shapes the culture of compliance and excellence within the organization.

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 global design controls and quality system regulations to stand out in your application.
  • Showcase your ability to lead cross-functional teams and influence global processes.
  • Highlight your experience with CAPA, audits, and risk management in your portfolio or resume.
  • Prepare to discuss how you stay updated with the latest regulatory standards and their applications.
  • Be ready to provide examples of your leadership and communication skills in a remote work setting.

This is a remote position listed on WFA Digital, the platform for professionals who work from anywhere. Browse more remote jobs across all categories.