Jobgether: Sr. Design Controls Lead - REMOTE

Salary: $99,300.00 - $198,700.00

Location: Remote

Introduction:

We are seeking a highly skilled Sr. Design Controls Lead to join our partner company in New Jersey. As a key player in ensuring compliance and efficiency in design control processes, you will collaborate closely with various departments including Regulatory, Quality, and R&D. This role not only influences product outcomes but also involves shaping the culture of compliance and excellence within the organization. If you have a strong background in Quality or R&D in the medical device industry and are looking for a challenging and rewarding opportunity, we encourage you to apply.

About the Company:

This position is posted by Jobgether on behalf of our partner company, a leading medical device company headquartered in New Jersey. With a strong focus on innovation and a commitment to quality, our partner company is dedicated to improving patient outcomes. They offer a collaborative and innovative team culture, opportunities for professional development and training, and a flexible remote work environment.

Responsibilities:

• Partner with cross-functional teams globally to optimize and streamline design control requirements for medical devices.
• Lead process development and improvement projects, ensuring adherence to global regulatory standards while supporting timely product releases.
• Develop and conduct training on design controls and related process changes.
• Audit design records to ensure compliance and address non-conformances.
• 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.

To find out more or apply for this role, please use the following link: Apply here

By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.