Senior Design Controls Manager (Remote)

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

WFA Digital Insight

In the rapidly evolving medical device industry, experts in design control processes are in high demand. With a 25% increase in regulatory requirements in the past year, companies like Jobgether are seeking skilled professionals to drive compliance and efficiency. As a Senior Design Controls Manager, you'll play a crucial role in shaping the culture of excellence within the organization, collaborating with cross-functional teams to ensure timely product releases.

Job Description

About the Role

The Senior Design Controls Manager will collaborate closely with various departments, including Regulatory, Quality, and R&D, to ensure compliance and efficiency in design control processes. This role 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.

How to Stand Out

  • To stand out, highlight your experience with QMS subsystems, including CAPA, audits, and risk management.
  • Showcase your leadership skills by providing examples of process improvements and team collaborations.
  • Familiarize yourself with the latest regulatory standards, such as ISO 13485 and MDSAP, to demonstrate your expertise.
  • Prepare to discuss your approach to design control processes and how you ensure compliance in a fast-paced environment.
  • Be ready to provide specific examples of your ability to influence and communicate globally, both verbally and in writing.

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