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Quality Assurance Engineer for Suppliers
2 months ago
Position: Supplier Quality Assurance Engineer
Company: Intellectt Inc
Overview:
The Supplier Quality Assurance Engineer plays a critical role within our Infectious Disease Developed Markets division. This position is responsible for ensuring that all procured materials, products, and services meet established quality standards and specifications.
Key Responsibilities:
- Oversee the Supplier Quality function, collaborating closely with Purchasing and the New Product Development and Engineering teams.
- Address supplier inquiries related to quality in a professional and timely manner. Manage supplier modifications through the change management system.
- Evaluate Supplier Validation Protocols to confirm compliance with regulatory and customer standards.
- Coordinate with engineering teams to schedule and conduct first article inspections, capability studies, and gage R&Rs for purchased products.
- Conduct thorough investigations and implement root cause analyses for product quality issues and defects, ensuring effective solutions are executed.
- Administer the Supplier corrective action process and enhance the Approved Supplier List (ASL).
- Utilize supplier scorecards and analytical tools to assess supplier performance and collaborate on improvement strategies.
- Set and prioritize tasks to meet quality expectations.
- Identify opportunities for continuous improvement in quality systems and processes.
- Perform external audits as necessary, based on established schedules or supplier performance issues.
- Fulfill additional responsibilities as required.
Qualifications:
- Bachelor's degree in Engineering, Manufacturing, Biology, or a related field, or equivalent experience.
- A minimum of 2 years of experience in the medical device sector, ideally in Quality or Supplier Engineering. Proficiency in Microsoft Word, PowerPoint, and Excel is essential.
Preferred Skills:
- Knowledge of federal regulations, including QSRs, ISO 13485, CMDR, IVDD/IVDR, and familiarity with 21 CFR Part 11 for Electronic Records and Signatures.
- Advanced skills in Microsoft Office Suite and a strong attention to detail.
- Excellent organizational abilities and task prioritization skills.
- Strong documentation and technical writing capabilities.
- Proficient verbal and written communication skills in English.
- Ability to build and maintain effective working relationships with both internal and external stakeholders.
- Capacity to adapt quickly to changing priorities and work independently with minimal supervision.
