Manufacturing Quality Engineer

at  Transmedics Inc

JOB DESCRIPTION

Position: Manufacturing Quality Engineer
Reports to: Director, Quality Assurance
Location: Andover, MA
TransMedics, Inc. is a medical technology company that is transforming solid organ transplantation for patients with end-stage heart, lung, and liver failure. The Organ Care System (OCS™), a first-in-class proprietary device/solution platform, was developed to improve quality, validate viability, and increase the utilization of donor organs for transplantation. TransMedics OCS™ Heart, OCS™ Lung, and OCS™ Liver systems currently have both U.S. PMA approvals and are CE-Marked. TransMedics is the undisputed global leader in organ transplantation in a new multi-billion-dollar medical device industry.
TransMedics is a rapidly growing organization dedicated to attracting and hiring top talent to deliver on our Mission to be the trusted partner to transplant stakeholders worldwide, focused on delivering the highest quality technology, services and clinical care to save patients’ lives.

BACKGROUND AND QUALIFICATIONS:

• Minimum of 5 years’ experience in a Manufacturing Quality and/or Manufacturing Engineering role
• Working knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485 as well other applicable regulations and industry standards pertaining to Medical Devices.
• Experience with manufacturing of complex products in an Environmentally controlled area. Experience with medical capital equipment and electromechanical devices preferred.
• Experience with formal problem-solving methodologies and deductive skills, root cause analysis & CAPA.
• Experience with handling non-conforming material and assemblies.
• Practical knowledge and experience using Minitab or other statistical analysis tools. Understanding & application of Gage R&R and Measurement system analysis desired.
• Utilization of statistical data analysis for trending purposes; ideally Six Sigma methods and tools
• Ability to communicate ideas and information clearly, effectively, and concisely.
  EDUCATION: BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline.

• Provide quality engineering support in the manufacturing of medical devices & hardware.
• Ensure compliance of manufacturing processes and areas to all applicable quality system regulations
• Lead Nonconformance (NCMR) process such as inspection methods, containment, correction, closure and CAPAs, and drive continuous improvement through analysis of trend data.
• Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities.
• Work with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP)
• Support the inspection & testing of raw materials, components & finished products to ensure compliance with specifications & quality standards.
• Resolve incoming inspection yield issues by driving tighter vendor process capabilities, ensuring appropriate internal drawing specifications, and validation of inspection methods.
• Lead analysis of defective components found in Incoming Inspection and work with suppliers to resolve (SCARs)
• Support internal auditing requirements in manufacturing to ensure compliance with quality system requirements.