Senior Supplier Quality Engineer

TransMedics, Inc.•Andover, MA

1d•Onsite

About The Position

POSITION SUMMARY The Senior Supplier Quality Engineer will be a leader on the Supplier Quality team, expected to be subject matter expert with regard to Supplier Quality processes and provide guidance and mentoring to junior team members. This position will support the development of the long term vision for TransMedics supplier quality and will execute both the tactical and strategic plans to support this vision. This position is onsite 5 days a week. Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships RESPONSIBILITIES This position is responsible for, but not limited to, the following: Monitor supplier performance and drive improvement and resolution of non-conformances directly with supplier through corrective action process. Establish and report on supplier Key Performance Indicators (KPIs). Manage the Approved Supplier List (ASL) and supplier audit schedule. Lead Supplier audit activities. Lead supplier change management process. Partner with engineering and procurement to identify and qualify new suppliers. Support NPI processes for purchased materials, including first article inspection and supplier process validations. Identify and implement improvements to supplier selection/qualification, supplier monitoring, and incoming inspection processes. Support the quality management system as required. Perform other TransMedics tasks and duties as assigned/required. MANAGEMENT RESPONSIBILITIES This position manages the following positions on a daily basis. This position will not have management responsibilities. PHYSICAL ATTRIBUTES Ability to lift up to 30 pounds unassisted Office Environment MINIMUM QUALIFICATIONS Bachelor's Degree in Engineering 6 plus years of experience in a medical device (or similarly regulated) manufacturing environment 2 plus years in supplier quality. PREFERRED QUALIFICATIONS Master's Degree Practical knowledge and experience using Minitab or other statistical analysis tools. Practical knowledge and understanding of various quality tools such as: Six Sigma DMAIC, FMEA, SPC, 8D Root Cause Analysis and Lean Manufacturing concepts. Working knowledge and practical application of 21 CFR Part 820, ISO 13485, ISO 9001. Understanding and application of Gage R&R and Measurement System Analysis. Thorough understanding of CAPA/SCAR and closed loop corrective action system. Process validation experience including IQ/OQ/PQ. Ability to communicate ideas and information clearly, effectively and concisely. Highly detail oriented with strong organization and prioritization skills. Must possess a high level of energy with the ability to handle multiple projects and changing priorities. Must be results-driven and exhibit a sense of urgency. Experience with Geometric Dimensional and Tolerancing (GD&T) and the ability to read blueprints Basic metrology knowledge. Computer knowledge and experience with Microsoft Office. Six sigma training/certification or Certified Quality Engineer/Auditor is a plus. 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. Every Organ Wasted is a Life Not Saved. 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 $112,400-$140,200 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. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. – aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.

Requirements

Bachelor's Degree in Engineering
6 plus years of experience in a medical device (or similarly regulated) manufacturing environment
2 plus years in supplier quality.

Nice To Haves

Master's Degree
Practical knowledge and experience using Minitab or other statistical analysis tools.
Practical knowledge and understanding of various quality tools such as: Six Sigma DMAIC, FMEA, SPC, 8D Root Cause Analysis and Lean Manufacturing concepts.
Working knowledge and practical application of 21 CFR Part 820, ISO 13485, ISO 9001.
Understanding and application of Gage R&R and Measurement System Analysis.
Thorough understanding of CAPA/SCAR and closed loop corrective action system.
Process validation experience including IQ/OQ/PQ.
Ability to communicate ideas and information clearly, effectively and concisely.
Highly detail oriented with strong organization and prioritization skills.
Must possess a high level of energy with the ability to handle multiple projects and changing priorities.
Must be results-driven and exhibit a sense of urgency.
Experience with Geometric Dimensional and Tolerancing (GD&T) and the ability to read blueprints
Basic metrology knowledge.
Computer knowledge and experience with Microsoft Office.
Six sigma training/certification or Certified Quality Engineer/Auditor is a plus.

Responsibilities

Monitor supplier performance and drive improvement and resolution of non-conformances directly with supplier through corrective action process.
Establish and report on supplier Key Performance Indicators (KPIs).
Manage the Approved Supplier List (ASL) and supplier audit schedule.
Lead Supplier audit activities.
Lead supplier change management process.
Partner with engineering and procurement to identify and qualify new suppliers.
Support NPI processes for purchased materials, including first article inspection and supplier process validations.
Identify and implement improvements to supplier selection/qualification, supplier monitoring, and incoming inspection processes.
Support the quality management system as required.
Perform other TransMedics tasks and duties as assigned/required.