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Supplier Quality Control Engineer
2 months ago
The Supplier Quality Engineer plays a crucial role in maintaining the integrity of the Supplier Quality Function. This position collaborates closely with Purchasing and the New Product Development and Engineering teams to ensure high-quality standards are met.
KEY RESPONSIBILITIES:- Oversee the Supplier Quality Function, providing support to Purchasing and Engineering teams.
- Address internal and external supplier inquiries related to quality in a timely and professional manner.
- Manage supplier modifications through the established change management system.
- Evaluate Supplier Validation Protocols to ensure 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 drive root cause analysis for product quality issues, implementing effective solutions.
- Administer the Supplier corrective action process, aiming to enhance the Approved Supplier List (ASL).
- Utilize supplier scorecards and analytical tools to assess supplier performance and collaborate on improvement strategies.
- Set and execute priorities to meet quality expectations.
- Identify opportunities for continuous improvement to enhance quality systems and processes.
- Perform external audits as necessary, based on the audit schedule or supplier performance issues.
- Execute additional responsibilities as required.
- 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.
- Proficient in MS Word, PowerPoint, and Excel.
- Knowledge of federal regulations, including QSRs, ISO 13485, CMDR, and IVDD/IVDR.
- Advanced proficiency in the MS Office Suite.
- 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 internal and external stakeholders.
- Adaptability to changing priorities and circumstances.
- Independent reasoning and minimal supervision required.
- Ability to analyze data and make informed decisions.
- Capability to maintain positive relationships with colleagues and external partners.
