Supplier Quality Engineer
Supplier Quality Engineer
Intellectt Inc
Northshore, FL
See who Intellectt Inc has hired for this role
Hi All,
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
Duration: Long Term Contract
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.
Responsibilities
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
Duration: Long Term Contract
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.
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.
- 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
- 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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