Quality Systems Engineer (Contract)

TransMedics•Andover, MA

About The Position

POSITION SUMMARY We are seeking a dynamic, analytical thinking individual to join our Quality team, this is a contract position focusing on Quality Systems, CAPA, Complaint handling, Internal Audit, metric reporting and process improvement initiatives. The ideal candidate will possess a strong background in medical devices or IVD, with a proven track record in managing quality-related activities in a fast-paced dynamic environment. QMS experience is essential. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Supports the overall QMS processes for the organization. Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding CAPA, complaints and internal/external audits. Additional responsibilities include supporting other QMS functions such as NCMRs, Supplier Controls, Management Review, Risk Review, etc. Execution and coordination of activities associated with CAPA program, including administration and record management, providing quality input to investigations, reporting, as well as metrics and trending Support CAPA Owners in quality-related technical principles, including but not limited to Problem Solving tools and techniques (Root Cause Analysis, DOE, FMEA, etc.) Investigate customer complaints, from intake through investigation and closure Manages the Internal Audit program, including scheduling audits, ensuring timely response to findings, as well as metrics and trending Development of Quality Metrics, and coordination of quality data collection and analyses for use in monthly metrics meetings and Management Reviews Provide quality assurance support cross-functionally across the organization Develop, implement, and manage Quality Control/Quality System process improvements. Identify opportunities for improvement within the Quality System to ensure compliance and efficiency. Correct or improve gaps/opportunities in an independent fashion by writing and releasing new or revised Quality System documentation Understand how and when to escalate quality issues to leadership team within the organization, presenting data and information necessary to draw conclusions and take action Provide training and support to employees on quality processes and procedures Support work on quality plans, quality processes and special projects, as required Perform other TransMedics tasks and duties as assigned/required

Requirements

Bachelor’s Degree in Engineering, Biomedical Science, or other technical discipline preferred, with 3-6 years of relevant experience in medical device industry, including responsibility for Product Quality and/or Quality Systems
A working knowledge of Quality System Standards and regulations, including 21 CFR Part 820, ISO 13485, EU MDR

Nice To Haves

Ability to multi-task, handling multiple projects and changing priorities
Experience in the creation and documentation of procedures and processes
Must be results-driven and exhibit a sense of urgency
Proficiency with Microsoft Office - Word, Excel, PowerPoint and Access experience required
Ability to communicate ideas and information clearly, effectively, and frequently (both oral and written)
Ability to exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results
Ability to act independently to determine methods and procedures
Problem-solving skills and the ability to resolve issues as they arise
Strong interpersonal skills, with the ability to assimilate with various cross-functional teams

Responsibilities

Supports the overall QMS processes for the organization.
Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding CAPA, complaints and internal/external audits.
Additional responsibilities include supporting other QMS functions such as NCMRs, Supplier Controls, Management Review, Risk Review, etc.
Execution and coordination of activities associated with CAPA program, including administration and record management, providing quality input to investigations, reporting, as well as metrics and trending
Support CAPA Owners in quality-related technical principles, including but not limited to Problem Solving tools and techniques (Root Cause Analysis, DOE, FMEA, etc.)
Investigate customer complaints, from intake through investigation and closure
Manages the Internal Audit program, including scheduling audits, ensuring timely response to findings, as well as metrics and trending
Development of Quality Metrics, and coordination of quality data collection and analyses for use in monthly metrics meetings and Management Reviews
Provide quality assurance support cross-functionally across the organization
Develop, implement, and manage Quality Control/Quality System process improvements.
Identify opportunities for improvement within the Quality System to ensure compliance and efficiency.
Correct or improve gaps/opportunities in an independent fashion by writing and releasing new or revised Quality System documentation
Understand how and when to escalate quality issues to leadership team within the organization, presenting data and information necessary to draw conclusions and take action
Provide training and support to employees on quality processes and procedures
Support work on quality plans, quality processes and special projects, as required
Perform other TransMedics tasks and duties as assigned/required