Job Description

Senior Quality Engineer – Salisbury, MA - $90k - $110k

US Citizens or GC holders only

No C2C

Are you a Senior Quality Engineer looking to lead and implement quality systems for Medical Device products in an ISO 13485 environment?

This role is critical in ensuring products meet rigorous Q uality and Regulatory standards across multiple industries, including M edical Devices . You will bring expertise in Q uality Management Systems, Regulatory compliance, and Manufacturing processes .

Key Responsibilities:

• Oversee and approve IQ, OQ, PQ validation protocols and execution for new and existing products.
• Manage PPAP activities and prepare submission packages.
• Lead Quality Technician functions and provide technical expertise.
• Participate in FMEA teams , ensuring risk mitigation in product development.
• Develop and document control plans, inspection procedures, and test methods .
• Conduct statistical capability studies and establish SPC control charts .
• Perform internal process audits to ensure compliance with specifications and SOPs.
• Monitor SPC charts to maintain process control and drive corrective actions when necessary.
• Train production staff on quality-related procedures and best practices.
• Support failure analysis, validation processes, and special testing as needed.
• Maintain Standard Operating Procedures (SOPs) and ensure regulatory compliance.
• Assist with software validation and supplier quality management .
• Provide audit support for internal, third-party, and customer audits .
• Lead continuous improvement initiatives and mentor quality and manufacturing engineers.

Qualifications & Experience:

• Bachelor’s degree in engineering or a related field.
• 3+ years of Quality Engineering experience, preferably in medical device manufacturing.

Expertise in:

• Validation activities (IQ, OQ, PQ, MSA).
• PPAP preparation and submission.
• FMEA/PFMEA participation.
• Root Cause Analysis & CAPA.
• Internal quality auditing.
• Supplier quality management.
• Software validation.
• Strong knowledge of ISO 13485, PPAP, FMEA, AIAG Control Plan Methodology, SPC, and GMP.
• ASQ Certified Quality Engineer (preferred).
• Proficiency in Microsoft Office and productivity tools.
• Excellent communication, analytical, and leadership skills.
• Occasional travel may be required.

⚠ Please Note: Candidates must be A uthorized to work in the U.S. Visa sponsorship (including H-1B) is not available for this role.

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