Senior Quality Systems Engineer

Regulatory Toolkit; Andover (MA); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical with Health Reimbursement

Dental

Vision

Flexible Spending Account

Dependent Care Flexible Spending

Short Term Disability

Long Term Disability

401K Plan

Pet insurance

Employee Stock Purchase Plan

Job summary

TransMedics is seeking a dynamic QA professional to join the Quality team, focusing on Quality Systems, CAPA, internal audits, metrics reporting, and process improvement. The ideal candidate has medical device or IVD experience and a solid background in QMS.

This four-month assignment supports CAPA activities, audits, data analysis, and cross-functional quality initiatives. You will help maintain compliance with 21 CFR Part 820, ISO 13485, and EU MDR while driving efficiency and continuous

Qualifications

• Bachelor’s degree in Engineering, Biomedical Science, or related field with 5–7 years in medical devices.
• Knowledge of QMS standards (21 CFR Part 820, ISO 13485, EU MDR).
• Ability to multi-task and manage shifting priorities in a fast-paced environment.
• Experience creating and documenting procedures and processes.
• Results-driven with sense of urgency and strong analytical skills.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Access).

Responsibilities

• Support QMS processes, CAPA, and audits; manage records and metrics.
• Coordinate CAPA activities, provide input to investigations and trending.
• Support Risk Management, FMEA, and quality plans.
• Develop and manage Quality Control/Quality System improvements.
• Provide training on quality processes across the organization.
• Prepare data for monthly metrics meetings and Management Reviews.
• Assist with external audits and inspections.

Skills

Quality Systems

CAPA

Internal Audit

Quality Metrics

Education

Bachelor’s Degree in Engineering, Biomedical Science, or related field

Tools

Microsoft Office

Job description

Job Description:

POSITION SUMMARY

We are seeking a dynamic, analytical thinking individual to join our Quality team, focusing on Quality Systems, CAPA, 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.This is a four month position to fill in while another employee is on leave.

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 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.)


• Manages the Internal Audit program, including scheduling audits, ensuring timely response to findings, as well as metrics and trending


• Support external audits and inspections by providing subject matter expertise


• 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


• Lead/participate in Risk Management and FMEA initiatives


• 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 escape 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

MINIMUM QUALIFICATIONS

• Bachelor’s Degree in Engineering, Biomedical Science, or other technical discipline preferred, with 5-7 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


• 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

PREFERRED QUALIFICATIONS

• Experience participating in internal and external audits, preferably serving as qualified internal auditor


• 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

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.