Quality Engineer

Location: Marlborough, MA and Londonderry, NH (onsite)

• We are seeking an experienced Quality Engineer / Project Manager contractor to support
• manufacturing process quality for Class II IVD diagnostic and electromechanical medical device production.
• This role is focused on floor-level manufacturing process quality and project execution (not design assurance, NPI, or supplier quality).
• The consultant will primarily function as a Project Manager for manufacturing process quality initiatives, and must be familiar with core quality engineering activities and terminology to effectively coordinate and drive the work.
• They will work directly on the production floor alongside Manufacturing Engineering, Validation Engineering, and Operations to keep process validation, quality remediation, and improvement activities moving on schedule.

• Approximately 8+ years of experience in project management / project coordination roles within medical device, IVD, or other regulated manufacturing environments
• Strong familiarity with manufacturing quality engineering concepts and activities (for example, validations, CAPA, PFMEA, control plans), even if not acting as the hands‑on technical QE
• Demonstrated experience leading and managing cross‑functional projects and work streams (formal PM certification not required)

• Act as the day‑to‑day project driver for manufacturing process quality initiatives across Marlborough, MA and Londonderry, NH.
• Use SharePoint and Smartsheet to track action items, owners, due dates, risks, and deliverables
• Run regular check‑ins with cross‑functional teams (Manufacturing Engineering, Validation, Operations, Quality) to review status, remove roadblocks, and keep activities on schedule
• Coordinate and document 1:1 check‑ins with key team members to follow up on critical tasks and ensure accountability
• Maintain and communicate clear timelines for validation, remediation, and quality improvement activities; elevate timing risks as needed
• Ensure project execution stays aligned to the existing strategy and roadmaps (no strategy creation required)