Senior Quality Engineer

Location:
Marlborough, Massachusetts (100% Onsite)

We are seeking an experienced and hands‑on Senior Quality Engineer to support manufacturing quality activities within a regulated medical device production environment. This role is focused on manufacturing process quality, production support, and process control execution and does not involve design assurance or supplier quality responsibilities

The ideal candidate will bring extensive experience supporting electromechanical medical device manufacturing, with a strong background in process validation, quality documentation, and continuous improvement initiatives. Experience with IVD products is a plus

• Provide day‑to‑day quality engineering support for manufacturing operation
• Drive and maintain production and process control activities to ensure product quality and compliance
• Support and execute Process Validation and Test Method Validation (TMV) activities
• Develop, maintain, and update PFMEAs, control plans, and critical quality metrics (CPQs/CTQs)
• Author and revise quality system documentation, including protocols, validation reports, CAPAs, risk assessments, and PFMEA
• Investigate quality issues, identify root causes, and support implementation of corrective and preventive action
• Collaborate closely with Manufacturing Engineering, Validation, Operations, and cross‑functional teams to improve manufacturing processes and product quality
• Ensure compliance with applicable quality standards, regulatory requirements, and internal procedures
• Provide hands‑on support on the manufacturing floor to address quality and process‑related challenges

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline
• Approximately 10 years of Quality Engineering experience within a medical device manufacturing environment
• Strong hands‑on experience supporting production quality and manufacturing process control
• Proven experience with electromechanical medical devices
• Solid knowledge of Process Validation, Test Method Validation (TMV), PFMEA, CAPA, PQs/CTQs
• Strong technical writing and documentation skills in regulated environments
• Ability to work independently while managing multiple priorities in a fast‑paced manufacturing setting
• Excellent communication and cross‑functional collaboration skills

• Experience with In Vitro Diagnostic (IVD) products
• Experience using Agile PLM or similar Product Lifecycle Management systems