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Supplier Quality Engineer
2 months ago
Job Title: Supplier Quality Engineer
Duration: Plymouth, MN
Job Summary:
As a Supplier Quality Engineer, you will play a critical role in ensuring the quality and compliance of materials and components sourced from suppliers. Your primary focus will be on developing, validating, and implementing test methods to evaluate supplier materials, ensuring they meet stringent industry and regulatory standards. You will collaborate with cross-functional teams to drive continuous improvement, enhance supplier performance, and support new product development initiatives.
Key Responsibilities:
- Lead the development, validation, and implementation of Test Method Validations (TMVs) for supplier-sourced materials and components, ensuring adherence to regulatory and industry standards.
- Collaborate with suppliers to ensure effective execution of test methods, including protocol development, testing, and data analysis.
- Conduct supplier audits to evaluate process capability, compliance with quality standards, and alignment with company requirements.
- Support supplier quality initiatives by monitoring supplier performance metrics, conducting root cause analysis, and implementing corrective and preventive actions (CAPA).
- Partner with cross-functional teams, including R&D, Quality, and Regulatory Affairs, to support New Product Development (NPD) and ensure quality objectives are met.
- Manage supplier-related non-conformances, lead investigations, and work closely with suppliers to implement corrective actions to improve performance.
- Participate in risk assessments, including Failure Modes and Effects Analysis (FMEA) and Process Validation, to ensure robust supplier processes.
- Provide technical support and guidance to suppliers to resolve quality issues and ensure compliance with Abbott’s requirements.
- Ensure that supplier processes and products comply with FDA, ISO 13485, and other applicable regulatory requirements.
Qualifications:
- Bachelor’s degree in Engineering, Quality, or a related field.
- Minimum 3-5 years of experience in Supplier Quality Engineering, with a strong focus on Test Method Validation (TMV).
- Experience working within FDA-regulated industries, preferably medical devices or pharmaceuticals.
- Strong knowledge of validation protocols, including IQ, OQ, PQ, and TMV methodologies.
- Familiarity with regulatory standards such as FDA, ISO 13485, and cGMP.
- Proven experience in supplier audits, CAPA processes, and supplier quality improvement initiatives.
- Excellent problem-solving skills and the ability to work cross-functionally with teams and suppliers.
- Strong communication and interpersonal skills, with the ability to collaborate effectively across teams.
