Intellectt Inc

Supplier Quality Engineer

Intellectt Inc Northshore, FL
Intellectt Inc

Supplier Quality Engineer

Intellectt Inc Northshore, FL
1 month ago 25 applicants

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

  • 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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