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Contract Inventory Associate - Shipping /Receiving (2nd Shift)
TransMedics, Inc.
Andover, MA
- $24 to $33 USD / hour
Added 3 days ago
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TransMedics, Inc.
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TransMedics, Inc.
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Clinical Support Associate - OCS Program - Teterboro, NJ
TransMedics, Inc.
WFH, NJ
- $77,000 USD / year
Added 8 days ago
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Clinical Support Associate - OCS Program - Raleigh/Durham, NC
TransMedics, Inc.
WFH, NC
- $77,000 USD / year
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Clinical Support Associate - OCS Program - Houston, TX
TransMedics, Inc.
6655 Travis St Suite 300 Houston, TX
- $77,000 USD / year
Added 8 days ago
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Clinical Support Associate - OCS Program - Atlanta, GA
TransMedics, Inc.
WFH, GA · Atlanta, GA
- $77,000 USD / year
Added 8 days ago
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Clinical Support Associate - OCS Program - Atlanta, GA
TransMedics, Inc.
WFH, IL · Atlanta, GA
- $77,000 USD / year
Added 8 days ago
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TransMedics, Inc.
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TransMedics, Inc.
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TransMedics, Inc.
WFH, CA
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TransMedics, Inc.
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Added 10 days ago
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TransMedics, Inc.
Andover, MA
Added 10 days ago
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TransMedics, Inc.
Andover, MA
Added 10 days ago
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Electro-Mechanical Assembler 1-4
TransMedics, Inc.
Andover, MA
- $23.94 to $29.9 USD / hour
Added 10 days ago
OCS Specialist- Kansas City, MO
TransMedics, Inc.
WFH, MO
Added 15 days ago
Senior Quality Systems Engineer
Transmedics Inc
Andover, MA

Transmedics Inc

Senior Quality Systems Engineer

Andover, MA, United States

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Job details

Posting language: English
Posted: Aug 30, 2019

Original job description

About Us

TransMedics is redefining what’s possible in organ transplantation. The Organ Care System (OCS™), our paradigm-shifting technology platform, is revolutionizing organ transplant. TransMedics OCS is a portable, ex-vivo, normothermic perfusion technology that mirrors human physiology, minimizes ischemia, and provides the ability to optimize donor organs during transport. This pioneering technology allows physicians and institutions to maximize the potential of donor lungs, hearts and livers, while monitoring each organ throughout the entire process, so that patients can experience better outcomes.

Responsibilities:

Maintains and improves Omnify Quality Management System software
Recommends and implements potential improvements or enhancements to quality systems and processes
Leads the Quality Audit system by managing the audit schedule and participating in and leading internal audits
Leads Quality aspects of the Supplier Management process, e.g., participate/lead supplier audits, presentation of trend data, etc.
Supports 3rd party audits (ISO, FDA, etc.)
Develops Quality Metrics, and coordinates quality data collection and analyses for Management Reviews
Manages the Corrective and Preventive Action (CAPA) system
Maintains SOP Training for the Company; ensures employees are assigned appropriate training plans
Ensures compliance of QMS through SOP updates and training
Identifies product and process improvements; leads and supports their implementation
Some travel may be required (approximately 5-10%)
Performs other TransMedics tasks and duties as required.

Requirements:

BS in Engineering or technical discipline with at least 8 years experience in Quality Systems Engineering in the medical device manufacturing industry, or equivalent combination of education and experience
Outstanding project management experience
Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations
Experience in medical device manufacturing and EtO sterilization of disposable medical devices
Experience with Quality Auditing to 21 CFR Part 820 and ISO 3485.
Excellent track record trouble-shooting and applying effective, systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues
Ability to communicate ideas and information clearly, effectively and concisely
Highly detailed oriented with strong organization and prioritization skills
Must possess the ability to handle multiple projects and changing priorities
Must be results-driven and exhibit a sense of urgency
Six sigma training/certification is a plus
Experience creating and working with databases, queries and reports is a plus

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More about this job

Skills

Quality control systems
Project management
Medical devices
Auditing
Problem solving
Prioritization
Lean manufacturing

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