Sr. Design Controls Lead - REMOTE

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

WFA Digital Insight

As demand for skilled design control professionals grows, Jobgether's remote Senior Design Controls Lead role stands out for its global scope and emphasis on compliance and efficiency. With a strong background in quality systems and regulatory standards, candidates can leverage their expertise to drive improvements in product development. Before applying, it's essential to understand the company's commitment to excellence and the role's potential impact on shaping the organization's culture.

Job Description

About the Role

The Senior Design Controls Lead will collaborate closely with various departments to ensure compliance and efficiency in design control processes, driving improvements across product development and supporting timely product releases.

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

  • Highlight your experience with Excel and QMS subsystems, such as CAPA and audits, to demonstrate your ability to manage global compliance.
  • Showcase your leadership skills by providing examples of process improvements you've led in previous roles.
  • Be prepared to discuss your understanding of regulatory standards, including QSR, ISO 13485, and MDSAP.
  • Emphasize your ability to collaborate with cross-functional teams and communicate effectively with global stakeholders.
  • Consider creating a portfolio that showcases your design control projects and process improvements to stand out as a candidate.

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