Jobgether: Lead Design Controls Manager (Remote)

Salary: $99,300.00 - $198,700.00

Location: Remote (Headquarters: California)

Are you a highly experienced Quality or R&D professional in the medical device industry? Are you passionate about driving compliance and excellence in design control processes? Look no further! Jobgether is currently seeking a Lead Design Controls Manager to join a partner company's team. This remote role offers a competitive salary, flexible working environment, and opportunities for professional growth and development.

Company Overview:

This position is posted by Jobgether on behalf of a partner company. Our client is a leading medical device company headquartered in California. With a strong focus on compliance and innovation, they have established themselves as a key player in the industry. They are committed to creating a collaborative and innovative team culture, offering comprehensive health benefits, and providing access to cutting-edge technologies and methodologies.

Key Responsibilities:

• Collaborate with various departments including Regulatory, Quality, and R&D to ensure compliance and efficiency in design control processes
• Lead process development and improvement projects globally
• Develop and conduct training on design controls and related process changes
• Audit design records to ensure conformity to global regulatory standards
• Perform gap analyses and propose updates to meet international regulatory 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 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
• Strong leadership skills and ability to influence and communicate globally
• Excellent 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