Sr Quality System Engineer (Contract)
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 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
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
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.
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Are you ready to take your career to the next level? TransMedics is on the lookout for a talented Sr Quality System Engineer to join our Quality team in Andover, Massachusetts. This exciting contract position will allow you to immerse yourself in Quality Systems, CAPA, Internal Audit, metric reporting, and process improvement initiatives, making a significant impact during your four-month tenure while a key team member is on leave. In this role, you'll be the backbone of our Quality Management Systems (QMS), ensuring compliance and supporting crucial activities like CAPA, NCMRs, and Supplier Controls, among others. If you have a strong background in the medical device or IVD sectors and possess a knack for analytical thinking, we want to hear from you! Your experience will be invaluable as you manage internal audits, assist during external inspections, and lead risk management efforts. You'll also coordinate quality data collection and analysis while actively participating in improving our Quality System processes. We're looking for someone with a Bachelor’s Degree in Engineering, Biomedical Science, or a related field, along with 5-7 years of relevant experience. Proficiency in Microsoft Office and strong problem-solving skills are essential, as well as the ability to communicate effectively across cross-functional teams. At TransMedics, we value diversity and are committed to creating an inclusive environment. Come join us, make a difference, and help elevate our quality standards!
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