Manager Quality Control

Job Description:

Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships

POSITION SUMMARY

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.

RESPONSIBILITIES

This position is responsible for, but not limited to, the following:

• 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

MANAGEMENT RESPONSIBILITIES

• This position manages the following positions on a daily basis.

• This position has responsibility for Group Leads and Inspectors in various roles within the

• QC department, including but not limited to Incoming Inspection, Cleanroom and Equipment and Service.

PHYSICAL ATTRIBUTES

• Physical Activities: • Mobility: Walking, standing, sitting, balancing, stooping, kneeling, crouching, reaching, pushing/pulling, lifting, carrying.

• Fine Motor Skills: Grasping, fine manipulation, feeling.

• Sensory Abilities: • Vision: Close vision, distance vision, color vision, peripheral vision, depth perception, ability to adjust focus.

• Hearing: Ability to perceive sounds at normal speaking levels, including ability to hear and understand spoken instructions.

• Other Senses: Ability to perceive smells, tastes, or textures as relevant to the job.

• Environmental Factors: • Temperature: Exposure to hot or cold environments.

• Noise: Exposure to loud or distracting noises.

• Hazards: Exposure to chemicals, machinery, or other potential dangers.

• Other Considerations: • Repetitive Tasks: Frequency and duration of repetitive movements.

• Mental/Emotional Demands: Stress levels, ability to handle change (tasks, workload).

• Equipment Use: Ability to operate specific tools or machinery.

• Safety: Ability to work safely and follow safety procedures.

MINIMUM QUALIFICATIONS

• At least 5 years’ experience in managing direct reports in a Quality Control function

• Manufacturing and sterilization (including cleanroom) experience

PREFERRED QUALIFICATIONS

• 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

As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary.

TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.

Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.

Maximize your potential at TransMedics, Inc.

www.TransMedics.com

TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $118,600.00 – $148,000.00, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.

Employee Benefit:

Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA

Dental

Vision

Healthcare Flexible Spending Account

Dependent Care Flexible Spending Account

Short Term Disability

Long Term Disability

401K Plan

Pet insurance

Employee Stock Purchase Plan

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.