Senior Manufacturing Quality Engineer

Job Description:

POSITION SUMMARY:

Trans Medics is looking for a Senior Manufacturing Quality Engineer that will develop, implement, and manage quality systems for manufacturing, focusing on process improvement, defect reduction, and compliance, involving root cause analysis (CAPA), audits, statistical process control (SPC), FMEAs, and training junior staff, while ensuring adherence to ISO/regulatory standards for high-quality, reliable products in a fast-paced, collaborative environment.

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

Utilization of statistical data analysis for trending and investigation purposes

Ability to communicate ideas and information clearly, effectively, and concisely

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 improvements 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

Partner with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP)
Partner with Manufacturing Engineering to implement and maintain electronic manufacturing and inspection work instructions within a Manufacturing Execution System (MES)
Oversee the inspection & testing of raw materials, components & finished products to ensure compliance with specifications & quality standards. Establish and maintain quality control procedures, including inspection methods and test protocols.

Support internal and external auditing requirements in manufacturing to ensure compliance with quality system requirements

Support other Quality Engineering functions as required (supplier quality, service, design QA)
Perform other Trans Medics task and duties as required

MANAGEMENT RESPONSIBILITIES This position manages the following positions on a daily basis.

This position will not have management responsibilities.

PHYSICAL ATTRIBUTESOffice and clean room environments

Ability to lift up to 25 pounds

MINIMUM QUALIFICATIONS Bachelor's Degree in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline.

Minimum of 8 years’ experience in a Manufacturing Quality and/or Manufacturing Engineering role

Experience with work instruction development and maintenance within an MES environment

PREFERRED QUALIFICATIONS 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 medical device products.

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.

Experience with process validation

Experience with non-product software implementation and validation

Familiarity with Manufacturing Execution Systems (MES) software

Experience presenting data and information to management, including senior and/or executive management

Every Organ Wasted is a Life Not Saved.

Trans Medics, 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…