Remote Design Controls Manager
Other
Excel
WFA Digital Insight
The demand for skilled design control professionals has seen significant growth, driven by the increasing complexity of global regulatory standards. With a strong background in quality management and a knack for process optimization, candidates can stand out in this role. Jobgether's commitment to excellence and compliance makes this an attractive opportunity for those who value making a meaningful impact on product development.
Job Description
About the Role
The Design Controls Manager will play a key role in ensuring compliance and efficiency in design control processes, collaborating closely with various departments. This remote position influences product outcomes and shapes the culture of compliance within the organization.Responsibilities
- Partner in optimizing design control requirements for medical devices.
- Lead process development and improvement projects with global teams.
- Conduct training on design controls and process changes.
- Ensure conformity to global regulatory standards.
Requirements
- BS in Management, Engineering, or Science preferred.
- 5+ years of Quality or R&D experience in a medical device company.
- In-depth knowledge of QSR, ISO 13485, and MDSAP.
- Expertise in QMS subsystems and design control.
How to Stand Out
- Develop a strong understanding of global regulatory standards, including QSR and ISO 13485, to stand out in your application.
- Showcase your ability to lead cross-functional teams and drive process improvements in your portfolio.
- Prepare to discuss your experience with design control processes and how you've ensured compliance in previous roles.
- Highlight your skills in Excel, as well as any other relevant tools or software.
- Be prepared to discuss your approach to mentoring teams and aligning them with company policies and procedures.
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