Job Title: Design Controls Leader (Remote)

Salary: $99,300.00 - $198,700.00

Location: Remote

Introduction:

Are you a talented Design Controls Manager with a passion for ensuring compliance and efficiency in design processes? Join Jobgether's partner company in their search for a remote Design Controls Leader. This is an exciting opportunity to collaborate with global teams and drive improvements in the medical device industry.

About the Company:

Headquartered in New York, Jobgether partners with leading organizations to connect top talent with career opportunities. This specific role is with a medical device company that prides itself on its culture of compliance and excellence. With a strong focus on innovation and a commitment to global regulatory standards, this company offers a dynamic and collaborative work environment.

Responsibilities:

• Partner with cross-functional teams to optimize and streamline design control requirements for medical devices.
• Lead process development and improvement projects globally.
• Develop and conduct training on design controls and related processes.
• Ensure conformity of processes and records to global regulatory standards.
• Perform gap analyses against international regulatory standards and propose updates.
• Mentor R&D and Quality Assurance teams to align with policies and procedures.
• Participate in audits as a design controls expert and company representative.
• Collaborate with R&D to ensure compliance in software tool implementations.

Requirements:

• Bachelor's degree 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 work independently and collaboratively.
• Willingness to travel 25%, including international trips.

Benefits:

• Competitive salary range from $99,300.00 to $198,700.00.
• Flexible remote work environment.
• Opportunities for professional development and training.
• Collaborative and innovative team culture.
• Comprehensive health benefits and wellness programs.
• Potential for periodic international travel.
• Support for continuing education and certifications.
• Access to cutting-edge technologies and methodologies.

Apply here