Quality Systems Engineer; Medical Devices Industry @ Andover, MA

Quality Systems Engineer (Medical Devices Industry) @ Andover, MA

Position Overview:

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:

• 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 elevate 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

Minimum Qualifications:

• 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

Preferred Qualifications:

• Ability to multitask, 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

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship or employment visas currently.

Next Phase.ai is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Contract

Mid-Senior level