Demo

Supplier Quality Engineer

Talentrupt RPO
Marlborough, MA Full Time
POSTED ON 11/13/2025
AVAILABLE BEFORE 1/12/2026
Job Title: Supplier Quality EngineerLocation: Marlborough, MA 01752Duration: 12 MonthsPay Rate: $55/hour Job Summary:The Supplier Quality Engineer provides critical support to the Global Supplier Quality organization, ensuring that all external suppliers meet Hologic’s quality and regulatory requirements for components, materials, and services. This role serves as a technical expert, partnering with suppliers and internal teams to drive continuous improvement, ensure product reliability, and maintain compliance with applicable standards and regulations.Key Responsibilities:Ensure compliance with regulatory standards and Hologic’s Quality Management System in all supplier-related quality activities.Conduct supplier technical capability reviews and audits to verify manufacturing and process quality controls.Oversee and approve PPAP (Production Part Approval Process) for new and revised purchased parts.Manage supplier corrective actions (SCARs, SACAs, NCEs) and monitor resolution timelines per company KPIs.Collaborate with R&D, Design Assurance, and Manufacturing Engineering to resolve supplier issues impacting product performance and reliability.Support problem-solving and root cause analysis, applying metrology and statistical tools where applicable.Coordinate containment, rework, or disposition activities for non-conforming supplier materials.Maintain complete and accurate supplier quality documentation, certifications, and performance metrics.Generate and present supplier performance reports to stakeholders and management.Support internal and external audits as a subject matter expert; domestic and international travel may be required.Participate in supplier onboarding and qualification for new products, product transfers, or alternate sourcing projects.Ensure that approved suppliers are properly updated in ERP systems and compliant with all applicable regulations. Qualifications & Skills:Strong verbal and written communication skills across all organizational levels.Proficient in problem-solving tools (SPC, TQM) and root cause analysis (CAPA).High proficiency in Microsoft Office; working knowledge of Project, Visio, Minitab, and Agile preferred.Understanding of medical device regulatory requirements: cGMP, CFR 820, ISO 13485, ISO 14971, ISO 9001.Experience in risk management, supplier audits, and quality system regulations.Knowledge of PPAP processes and statistical sampling techniques.Strong project management and multitasking capabilities.ISO 13485 Lead Auditor certification and ASQ Supplier Quality Engineer certification preferred. Education & Experience:Bachelor’s degree in engineering (Mechanical, Electrical, Mechatronics, or Plastics preferred).Minimum 2 years of relevant experience in supplier quality or manufacturing engineering within the medical device or regulated industry.Experience working with quality management systems and supplier oversight programs.Valid driver’s license required (clean record preferred).

Salary : $55

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