Global Technical Talent
Primary Job Title
Quality Engineer Alternate/Related Job Titles
Supplier Quality Engineer Manufacturing Quality Engineer Process Quality Engineer Quality Assurance Engineer Location
Marlborough, MA Onsite Flexibility
Onsite Contract Details
Position Type:
Contract Contract Duration:
12 months Start:
As Soon As Possible Pay Rate:
$55/hour Job Summary
The Quality Engineer supports the Global Supplier Quality organization by ensuring compliance with regulatory and quality management standards for components, materials, and services. This role provides technical expertise to evaluate supplier capabilities, manage performance metrics, oversee audits, and support continuous improvement initiatives across the global supply chain. The engineer will also work closely with cross‑functional teams—including R&D, Design Assurance, Manufacturing, and Post Market Surveillance—to maintain the highest standards of product safety and reliability. Key Responsibilities
Execute all activities necessary to comply with Quality Management System (QMS) requirements and regulatory standards (FDA, ISO 13485, ISO 14971, ISO 9001). Conduct technical reviews of suppliers to evaluate capability, quality control, and manufacturing practices. Oversee supplier performance in process validation, corrective actions, and First Article Inspections. Define and approve PPAP (Production Part Approval Process) requirements for new and revised parts; ensure timely completion. Manage and track supplier corrective actions (SCARs, SACAs, NCEs) using Agile Quality systems. Collaborate with suppliers to perform root cause analysis and implement preventive measures. Support internal and external audits as a subject matter expert. Partner with Post Market Surveillance to resolve supplier‑related complaints. Drive nonconformance resolution through containment, rework, or return‑to‑supplier processes. Maintain accurate supplier quality records, certifications, and key performance metrics. Lead or support supplier qualification, onboarding, and periodic review activities. Generate and present supplier performance reports to internal stakeholders. Coordinate and execute new supplier implementation activities aligned with new product introductions or transfers. Ensure regulatory compliance across all applicable markets (FDA, Canada, Brazil, Japan, etc.). Required Qualifications
Bachelor’s degree in Engineering
(Mechanical, Electrical, Mechatronics, or related field). Minimum 2 years
of professional experience in the medical device industry, focused on supplier or manufacturing quality. Strong understanding of cGMP, QSR (21 CFR 820), ISO 13485, and ISO 14971 standards. Proven experience with CAPA, root cause analysis, and process validation (IQ/OQ/PQ). Working knowledge of statistical process control (SPC) and quality measurement tools. Excellent written and verbal communication skills; able to interact across all levels of the organization. Proficiency in Microsoft Office, Agile PLM, and Minitab (desirable). Preferred Skills
ISO 13485 Lead Auditor
certification. ASQ Supplier Quality Engineer
certification (preferred). Knowledge of measurement system analysis (GR&R, AAA). Familiarity with risk management and validation processes. Experience with Project, Visio, and data analysis tools. Second language proficiency is a plus. Physical Demands
Ability to sit, stand, walk, kneel, or crouch as required. Exposure to mechanical parts and moderate noise in manufacturing environments. Must wear safety shoes in designated areas. Ability to travel domestically and internationally as needed. Benefits
Medical, Vision, and Dental Insurance Plans 401(k) Retirement Fund
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Quality Engineer Alternate/Related Job Titles
Supplier Quality Engineer Manufacturing Quality Engineer Process Quality Engineer Quality Assurance Engineer Location
Marlborough, MA Onsite Flexibility
Onsite Contract Details
Position Type:
Contract Contract Duration:
12 months Start:
As Soon As Possible Pay Rate:
$55/hour Job Summary
The Quality Engineer supports the Global Supplier Quality organization by ensuring compliance with regulatory and quality management standards for components, materials, and services. This role provides technical expertise to evaluate supplier capabilities, manage performance metrics, oversee audits, and support continuous improvement initiatives across the global supply chain. The engineer will also work closely with cross‑functional teams—including R&D, Design Assurance, Manufacturing, and Post Market Surveillance—to maintain the highest standards of product safety and reliability. Key Responsibilities
Execute all activities necessary to comply with Quality Management System (QMS) requirements and regulatory standards (FDA, ISO 13485, ISO 14971, ISO 9001). Conduct technical reviews of suppliers to evaluate capability, quality control, and manufacturing practices. Oversee supplier performance in process validation, corrective actions, and First Article Inspections. Define and approve PPAP (Production Part Approval Process) requirements for new and revised parts; ensure timely completion. Manage and track supplier corrective actions (SCARs, SACAs, NCEs) using Agile Quality systems. Collaborate with suppliers to perform root cause analysis and implement preventive measures. Support internal and external audits as a subject matter expert. Partner with Post Market Surveillance to resolve supplier‑related complaints. Drive nonconformance resolution through containment, rework, or return‑to‑supplier processes. Maintain accurate supplier quality records, certifications, and key performance metrics. Lead or support supplier qualification, onboarding, and periodic review activities. Generate and present supplier performance reports to internal stakeholders. Coordinate and execute new supplier implementation activities aligned with new product introductions or transfers. Ensure regulatory compliance across all applicable markets (FDA, Canada, Brazil, Japan, etc.). Required Qualifications
Bachelor’s degree in Engineering
(Mechanical, Electrical, Mechatronics, or related field). Minimum 2 years
of professional experience in the medical device industry, focused on supplier or manufacturing quality. Strong understanding of cGMP, QSR (21 CFR 820), ISO 13485, and ISO 14971 standards. Proven experience with CAPA, root cause analysis, and process validation (IQ/OQ/PQ). Working knowledge of statistical process control (SPC) and quality measurement tools. Excellent written and verbal communication skills; able to interact across all levels of the organization. Proficiency in Microsoft Office, Agile PLM, and Minitab (desirable). Preferred Skills
ISO 13485 Lead Auditor
certification. ASQ Supplier Quality Engineer
certification (preferred). Knowledge of measurement system analysis (GR&R, AAA). Familiarity with risk management and validation processes. Experience with Project, Visio, and data analysis tools. Second language proficiency is a plus. Physical Demands
Ability to sit, stand, walk, kneel, or crouch as required. Exposure to mechanical parts and moderate noise in manufacturing environments. Must wear safety shoes in designated areas. Ability to travel domestically and internationally as needed. Benefits
Medical, Vision, and Dental Insurance Plans 401(k) Retirement Fund
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