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Supplier Quality Assurance Specialist
2 months ago
Position: Supplier Quality Assurance Specialist
Company: Intellectt Inc
Job Overview:
The Supplier Quality Assurance Specialist plays a crucial role in ensuring the quality and compliance of products sourced from suppliers. This position involves close collaboration with various teams, including Purchasing and Engineering, to uphold the standards of quality throughout the supply chain.
Key Responsibilities:
- Oversee the Supplier Quality Assurance function, providing support to the Purchasing and New Product Development teams.
- Address supplier inquiries related to quality in a professional and timely manner.
- Manage supplier modifications through the established change management protocols.
- Evaluate Supplier Validation Protocols to confirm adherence to regulatory and customer standards.
- Coordinate with engineering teams to plan and execute first article inspections, capability studies, and gage R&Rs for purchased products.
- Conduct thorough investigations into product quality issues, implementing effective solutions and assisting with the Corrective Action process as necessary.
- Administer the Supplier corrective action process, striving for improvements in the Approved Supplier List (ASL).
- Utilize supplier performance metrics and scorecards to assess and enhance supplier quality performance.
- Set and prioritize tasks to meet quality expectations effectively.
- Identify opportunities for continuous improvement within quality systems and processes.
- Perform external audits as needed to ensure suppliers meet established quality benchmarks.
Qualifications:
Applicants should possess a Bachelor’s degree in Engineering, Manufacturing, Biology, or a related field, or an equivalent combination of education and experience. A minimum of 2 years of experience in the medical device sector, particularly in Quality or Supplier Engineering, is preferred.
Skills:
- Proficiency in Microsoft Office applications, including Word, PowerPoint, and Excel.
- Familiarity with relevant regulations such as QSRs, ISO 13485, and CMDR.
- Strong attention to detail and accuracy.
- Excellent organizational skills with the ability to prioritize effectively.
- Exceptional documentation and technical writing capabilities.
- Strong verbal and written communication skills in English.
- Ability to build and maintain effective working relationships with both internal teams and external partners.
- Capacity to adapt to changing priorities and make sound judgments based on data interpretation.
