Overview
Senior Quality Engineer Jobs in Massachusetts, United States at United Pharma Technologies Inc
Title: Senior Quality Engineer
Company: United Pharma Technologies Inc
Location: Massachusetts, United States
Senior Quality Engineer / Project Manager
Location: Marlborough, MA
Duration: 6 Months
Position Summary
We are seeking an experienced Quality Engineer / Project Manager contractor to support manufacturing process quality activities for Class II IVD diagnostic and electromechanical medical device production. This role is focused on manufacturing process quality and project execution within a regulated production environment and does not include Design Assurance, New Product Introduction (NPI), or Supplier Quality responsibilities.
Key Responsibilities
Project Management & Execution
- Serve as the day-to-day project lead for manufacturing process quality initiatives across Marlborough, MA and Londonderry, NH facilities.
- Utilize SharePoint and Smartsheet to manage action items, ownership, due dates, project risks, and deliverables.
- Facilitate regular cross-functional meetings with Manufacturing Engineering, Validation, Operations, and Quality teams to review progress, address challenges, and maintain project schedules.
- Coordinate and document one-on-one follow-up meetings with key stakeholders to ensure accountability and timely completion of critical tasks.
- Develop, maintain, and communicate project timelines for validation, remediation, and quality improvement activities.
- Identify and escalate schedule risks and project roadblocks as necessary.
- Ensure all project activities remain aligned with established strategies, roadmaps, and organizational objectives.
Required Experience
- 8+ years of experience in project management or project coordination roles within medical device, IVD, or other regulated manufacturing environments.
- Strong understanding of manufacturing quality engineering concepts, including:
- Process Validation
- CAPA (Corrective and Preventive Actions)
- PFMEA (Process Failure Mode and Effects Analysis)
- Control Plans
- Proven experience leading and coordinating cross-functional projects and workstreams.
- Formal Project Management certification is not required.
Preferred Qualifications
- Experience in Class II IVD diagnostic manufacturing environments.
- Exposure to high-volume liquid reagent filling operations.
- Experience supporting large-scale electromechanical assembly manufacturing.
- Familiarity with EU IVDR requirements.
- Comfortable working directly on the production floor alongside operators, engineers, and supervisors.
Technical Skills & Tools
- Proficiency with SharePoint and Smartsheet for project tracking, dashboards, reporting, and documentation.
- Strong documentation experience, including:
- Validation Protocols and Reports
- CAPAs
- PFMEAs
- Control Plans
- Excellent communication, collaboration, and stakeholder management skills.
- Ability to drive accountability across multiple teams and ensure adherence to project timelines.
