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Dir, Design Assurance

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Director, Design Assurance is responsible for overseeing the compliance of the design and development process and risk management process for FMI. The Director manages and oversees global initiatives as they impact the design and development activities for FMI.

This person is responsible for the design, development, implementation, and maintenance of a compliant and effective risk management system. This includes partnering with the R&D organization to ensure processes are compliant, dynamic, and agile to meet the demands of the business. The role is responsible for identifying and securing needed resources to ensure effectiveness.

Key Responsibilities

• Partner with FMI senior management and site management to facilitate new product development quality activities.

• Partner with cross functional team members to drive quality improvement activities and lean principles within the organization.

• Ensure that design and development practices incorporate current global regulatory compliance expectations as required by FDA QSR, ISO 13485, IVDR, ISO 14971.

• Responsible for directing the efforts associated with QA functions related to design quality engineering and design change management.

• Lead design quality engineering and technical support for product realization and market release.

• Ensure development projects are resourced and supported through the design process.

• Assist in establishing robust programs to ensure new products are designed for manufacturability and compliant to all applicable regulations.

• Manage the process for risk management activities throughout the product lifecycle.

• Function as the Subject Matter Expert on design, development, and risk management matters.

• Lead design transfer activities to ensure success of new designs in manufacturing.

• Function as the quality champion for IT projects impacting the design assurance function and/or systems.

• Design, establish, implement, and maintain a resource plan that fully supports the needs of the business to support growth initiatives.

• Maintain availability to work outside of regularly scheduled shift.

• Travel domestically up to 30% of the time.

Qualifications

Basic Qualifications

• Bachelor’s Degree ideally in science, engineering, or related field

• 5+ years of experience managing Quality Assurance in the Medical Device Industry

• 10+ years of experience working in the Medical Device Industry

• Experience with In Vitro Diagnostics

Preferred Qualifications

• Advanced degree is a plus

• Continuous improvement experience preferred (6 Sigma, Lean, GreenBelt/Black Belt)

• Extensive knowledge of ISO 13485, FDA CFR 820, IVDR, ISO 14971 and emerging standards/regulations

• Ability to work in a matrixed organizational structure, developing strong relationships with all levels of management

• Demonstrated experience providing guidance and counsel to site and line staff

• Demonstrated use of time management skills to drive individual/team projects to scheduled completion

• Excellent team building and leadership skills that motivate team members to drive projects to a successful conclusion – ability to manage and lead without direct authority

• Strong data analysis skills

• Strong interpersonal, verbal, and written communication skills

• Exceptional organizational, negotiation, and problem-solving skills

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion

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Internal applicants, please use your FMI email address.

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