Jobgether: Design Controls Manager - REMOTE

Salary: $99,300.00 - $198,700.00 per year, remote position

Are you a highly experienced Quality or R&D professional with a passion for driving compliance and efficiency in design control processes? Do you have a strong background in medical device companies and a thorough understanding of global regulatory standards? If so, we have an exciting opportunity for you to join our partner company as a Design Controls Manager - REMOTE.

About the Company:

Our partner company, headquartered in Arizona, is a leading player in the medical device industry. With a strong commitment to compliance and excellence, they are dedicated to providing innovative and life-changing products to customers worldwide. Join a collaborative and innovative team culture, with opportunities for professional development and a flexible remote 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.
• Conduct training on design controls and related process changes.
• Ensure conformity to global regulatory standards.
• Audit design records and address non-conformances.
• Perform gap analyses against international regulatory standards.
• 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.

Requirements:

• Bachelor's degree in Management, Engineering, or Science (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.

Apply here

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