Sr. Design Controls Manager - remote

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

WFA Digital Insight

As the demand for skilled design control professionals grows, Jobgether's remote Sr. Design Controls Manager role stands out. With a focus on medical devices, candidates with experience in Quality System Regulation and ISO 13485 are in high demand. Before applying, consider highlighting your leadership skills and expertise in global regulatory standards.

Job Description

About the Role

Jobgether is seeking a Sr. Design Controls Manager to collaborate with various departments, including Regulatory, Quality, and R&D, to drive improvements across product development processes.

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

  • Tip: Highlight your experience with Excel and other relevant design control tools in your application
  • Tip: Showcase your ability to lead cross-functional teams and drive process improvements
  • Tip: Be prepared to discuss your knowledge of global regulatory standards, such as ISO 13485 and MDSAP, in the interview
  • Tip: Demonstrate your expertise in design control processes and QMS subsystems, such as CAPA and risk management
  • Tip: Tailor your application to the specific requirements of the role, emphasizing your relevant experience and skills

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