Manager Quality Control

TransMedics, Inc.•Andover, MA

About The Position

The Manager, Quality Control position ensures the products are compliant to internal and external standards, safety regulations, and customer expectations by developing processes, inspecting outputs, and managing QC teams. Key responsibilities include managing and mentoring staff, analyzing data, and mitigating defects.

Requirements

At least 5 years’ experience in managing direct reports in a Quality Control function
Manufacturing and sterilization (including cleanroom) experience

Nice To Haves

BS in Engineering or Life Sciences or equivalent combination of education and experience
Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations. Experience with MDR a plus.
Knowledge of statistical techniques.
Proficient in MS Office Suite (i.e. Word, Excel, PowerPoint, Access).
Must be team-oriented and collaborative
Excellent interpersonal skills demonstrating the ability to work with others in a professional positive and collaborative manner
Ability to work in a fast-paced environment and to meet tight deadlines
Willingness to learn, possess a can-do attitude, and motivated to succeed and grow
Ability to multi-task with strong attention to detail
Proven Ability to provide logical, in-depth analysis of a problem or situation

Responsibilities

Overall management of quality control activities; oversee the development and implementation of robust systems and procedures to ensure evaluation, measurement and improvement of processes.
Manage inspectors and inspection processes of medical devices. (1st shift)
Carry out supervisory responsibilities including training, planning, directing, mentoring and appraising performance.
Participate in the management of the non-conformance system and efforts toward continuous process improvement and business automation.
Responsible for the periodic review of inspection processes and procedures.
Supports technical aspects of the inspection process, including investigation of complaints.
Supports manufacturing operations in product and new product development
Ensure the Quality Control department complies with 21CFR820, ISO 13485, MDSAP and MDR
Responsible for the application and maintenance of quality standards and the quality management system as they apply to products and services
Support audits to demonstrate compliance of quality control systems
Perform other TransMedics tasks and duties as required
Lead and support initiatives to drive simplification and integration of quality system requirements and business processes to ensure compliance and facilitate business growth