Jobgether: Sr. Design Controls Manager - Remote

Salary: $99,300.00 - $198,700.00

Location: Remote (Headquarters: Colorado)

About the Company

This position is posted by Jobgether on behalf of a partner company. With a mission to revolutionize the hiring process using AI-powered matching, Jobgether is dedicated to connecting top talent with the best opportunities. Our partner company is a leader in the medical device industry, known for their innovative products and commitment to compliance and quality. With a collaborative and innovative team culture, they offer a flexible and remote work environment, along with opportunities for professional growth and development.

Responsibilities

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

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.

Why Apply Through Jobgether?

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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

https://weworkremotely.com/remote-jobs/jobgether-sr-design-controls-manager-remote