Jobgether: Design Controls Manager REMOTE

Salary: $99,300.00 - $198,700.00

Location: Remote

Are you an experienced Quality or R&D professional with a passion for driving compliance and efficiency in design control processes? Jobgether is currently seeking a Design Controls Manager to join a partner company's team. In this role, you will collaborate with various departments to ensure adherence to global regulatory standards and drive improvements across product development processes. This is a unique opportunity to not only influence product outcomes but also shape the culture of compliance and excellence within the organization.

About the Company:

Jobgether is partnering with an innovative and growing medical device company headquartered in Texas. With a mission to improve patient outcomes, this company is a leader in the industry and offers a collaborative and innovative team culture. Employees have access to cutting-edge technologies and methodologies, as well as opportunities for professional development and training.

Key Responsibilities:

• Partner with cross-functional teams globally to optimize and streamline design control requirements for medical devices.
• Lead process development and improvement projects.
• Develop and conduct training on design controls and related process changes.
• Ensure conformity to global regulatory standards and address non-conformances.
• Perform gap analyses against international regulatory standards and propose updates.
• Maintain expertise in global design controls and related standards.
• 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.

Job 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.
• 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

Data Privacy Notice:

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.

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