Jobgether: Remote Design Controls Manager

Salary: $99,300.00 to $198,700.00 per year

Location: Remote

Are you a skilled Quality or R&D professional with experience in the medical device industry? Do you have in-depth knowledge of global regulatory standards and a passion for driving process improvements? If so, we have the perfect opportunity for you! Join our partner company as a Remote Design Controls Manager and play a key role in ensuring compliance, efficiency, and excellence in design control processes.

As a Design Controls Manager, you will collaborate closely with various departments, including Regulatory, Quality, and R&D, to drive improvements across product development processes. Your expertise will be critical in ensuring adherence to global regulatory standards and supporting timely product releases. This role not only has a direct impact on product outcomes but also involves shaping the culture of compliance and excellence within the organization.

About the Company:

This position is posted by Jobgether on behalf of our partner company. With headquarters in Florida, our partner is a leading medical device company dedicated to improving the lives of patients worldwide. Their innovative products and commitment to quality have established them as a trusted leader in the industry. Join a collaborative and innovative team culture that values professional development, work-life balance, and employee well-being.

Key Responsibilities:

• Partner with cross-functional teams globally to optimize and streamline design control requirements for medical devices.
• Lead process development and improvement projects.
• Conduct and develop training on design controls and related process changes.
• Ensure conformity of processes and records to global regulatory standards.
• Audit design records 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.

Job Specifications:

• 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

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