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

WHO WE ARE

Nextphase.ai is a Data Management solution provider focused on Data Operations services for enterprise data in the cloud. We are leading the innovation agenda with our clients by delivering a portfolio of services to help them improve data quality and manage data governance for their cloud data. NextPhase.ai data management services are tailored to achieve our clients business outcomes thus enabling our clients to focus on monetizing their data while we handle data operations. Nextphase.ai provides you with a dynamic and fun work environment and encourages you to use creative thinking to solve client challenges.

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 :

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

Minimum Qualifications :

Preferred Qualifications :

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.

NextPhase.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.