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One of my clients is looking Role: Supplier Quality Engineer, if you’re interested or your skills matches, please share with me your updated resume to sohail@intellectt.com
Title: Supplier Quality Engineer
Location: Northshore, MA
Job Description
The consultant will be a subject matter expert for evaluating, monitoring, and improving the quality of products and services delivered by external suppliers. This role involves working closely with suppliers, cross-functional teams, and internal quality departments to maintain high standards of product quality, safety, and regulatory compliance.
Key Responsibilities
Quality Standards: Develop and maintain supplier quality standards, specifications, and inspection criteria. Ensure suppliers adhere to these standards.
Participate in assigned tasks following supplier audits (identify non-conformances, and drive corrective and preventive action)
Supplier Performance: Monitor and report on supplier performance metrics, such as defect rates, on-time delivery, and quality improvement initiatives.
Root Cause Analysis: Investigate and analyze quality issues and non-conformances, working with suppliers to identify root causes and implement corrective actions.
Quality Improvement: Initiates collaboration with suppliers to implement quality improvement plans, including process changes, quality control methods, and continuous improvement initiatives.
Regulatory Compliance: Ensure suppliers meet all relevant regulatory and industry quality standards and requirements, particularly in regulated industries (e.g., medical devices, aerospace).
Risk Management: Identify and mitigate quality and supply chain risks associated with supplier activities.
Cross-functional Collaboration: Work closely with internal departments such as procurement, engineering, manufacturing, and quality assurance to ensure alignment and effective communication with suppliers.
Documentation: Maintain accurate and up-to-date records of supplier quality activities, audits, and quality agreements.
Job Qualifications
Bachelor’s degree required in a related Engineering discipline
4-10+ years of experience in Supplier Quality in the medical device field
Experience with manufacturing of complex products in an ECA, ideally catheter-based or cardiac assist devices is preferred
Supplier quality control experience
Experience with formal problem-solving methodologies and deductive skills
Good understanding of FDA QSRs, ISO13485, Ordinance 169, ISO14971
Experience with handling non-conforming material and assemblies; including root cause investigations pertaining to such non-conformities
Experience with internal and supplier audits of manufacturing processes
Utilized statistical data analysis for trending purposes; ideally utilized Six Sigma methods and tools
Experience with SAP or other ERP system is a plus
Must Haves/ Non-negotiable
The main activity is closing out non-conformance reports
Continuous improvement activities.
Experience with suppliers - ability to escalate issues if risk identified
Supplier Management SOPs experience
Med tech/ med-device experience
Personality is huge- must have a good quality mindset, be easy-going, and be able to integrate with the Abiomed team
Team mentality
SCARS experience
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Staffing and Recruiting
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