Manager Quality Control

TransMedics, Inc.•Andover, MA

17d•$118,600 - $148,000

About The Position

The Manager, Quality Control ensures products comply with internal and external standards, safety regulations, and customer expectations by developing processes, inspecting outputs, and managing QC teams. The role oversees quality control activities and systems, manages staff and inspection processes for medical devices, and supports continuous improvement, complaint investigations, manufacturing operations, and new product development. The position also maintains quality standards and the quality management system, supports audits, and ensures the QC department complies with 21 CFR 820, ISO 13485, MDSAP, and MDR. The role manages Group Leads and Inspectors across areas including Incoming Inspection, Cleanroom, and Equipment and Service. Inspection operations are identified as first shift.

Requirements

At least 5 years of experience managing direct reports in a Quality Control function.
Manufacturing and sterilization experience, including cleanroom experience.

Nice To Haves

Bachelor of Science in Engineering or Life Sciences, or an equivalent combination of education and experience.
Thorough knowledge and understanding of FDA QSR and ISO 13485 regulations; experience with MDR is a plus.
Knowledge of statistical techniques.
Proficiency in MS Office Suite, including Word, Excel, PowerPoint, and Access.
Team-oriented and collaborative approach.
Excellent interpersonal skills and ability to work with others in a professional, positive, and collaborative manner.
Ability to work in a fast-paced environment and meet tight deadlines.
Willingness to learn, a can-do attitude, and motivation to succeed and grow.
Ability to multitask with strong attention to detail.
Proven ability to provide logical, in-depth analysis of a problem or situation.

Responsibilities

Manage overall quality control activities and oversee development and implementation of systems and procedures to evaluate, measure, and improve processes.
Manage inspectors and inspection processes for medical devices.
Train, plan, direct, mentor, and appraise staff performance.
Participate in management of the non-conformance system and efforts toward continuous process improvement and business automation.
Periodically review inspection processes and procedures.
Support technical aspects of inspection, including complaint investigations.
Support manufacturing operations and product and new product development.
Ensure the Quality Control department complies with 21 CFR 820, ISO 13485, MDSAP, and MDR.
Apply and maintain quality standards and the quality management system as they apply to products and services.
Support audits demonstrating compliance of quality control systems.
Lead and support initiatives to simplify and integrate quality system requirements and business processes to ensure compliance and facilitate business growth.
Perform other TransMedics tasks and duties as required.
Manage Group Leads and Inspectors in QC, including roles in Incoming Inspection, Cleanroom, and Equipment and Service.