Design Controls Manager (Remote)
Other
Excel
WFA Digital Insight
As the demand for medical device professionals with expertise in design control processes grows, Jobgether's remote Design Controls Manager role stands out for its global scope and focus on compliance. With 5+ years of experience in Quality or R&D, candidates can leverage their knowledge of QSR, ISO 13485, and MDSAP to drive improvements in product development. Before applying, consider showcasing leadership skills and the ability to influence global teams.
Job Description
About the Role
Jobgether is seeking a Design Controls Manager to ensure compliance and efficiency in design control processes. This remote role involves collaborating 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
- Perform gap analyses against international regulatory standards and propose updates
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
- Experience leading design processes in a medical device context
- Demonstrated leadership and ability to influence and communicate globally
- Strong written, verbal, and interpersonal communication skills
- Ability to use Excel
How to Stand Out
- To stand out, highlight specific examples of design control process improvements you've led in previous roles.
- Ensure your resume and cover letter demonstrate a deep understanding of QSR, ISO 13485, and MDSAP regulations.
- Prepare to discuss your experience with audit processes and how you've addressed non-conformances.
- Showcase your ability to communicate complex regulatory information to cross-functional teams.
- Consider creating a portfolio that highlights your design control and quality management skills.
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