Supplier Quality Engineer

Katalyst CRO; Lafayette (CO); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in the United States is seeking a Supplier Quality Engineer to ensure quality parts, materials, and services from suppliers across the lifecycle.

You will qualify suppliers, lead PPAP reviews, drive GMP compliance, and support NPD with quality guidance; manage audits and supplier change management to uphold product quality and reliability.

Qualifications

• Bachelor degree required.
• Minimum 4 years of relevant experience.
• Experience with GMP/PPAP preferred.

Responsibilities

• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards through supplier assessments, process validation reviews, and evaluation of PPAP documentation.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to audit designated suppliers for GMP and quality standards.
• Evaluates suppliers' internal functions to assess performance and provide feedback.
• Provides Pre-Market Quality Engineering support to New Product Development (NPD) in partnership with Component Engineering and Post-Market Supplier Quality Teams.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle.
• Collaborates with Component Engineers to develop Product Acceptance Sampling Strategy and Control Plans for new products.
• Define Receiving Inspection requirements and test method validation for internal Test Methods.
• Supports supplier change management activities including site transfers, process changes, and material changes through risk assessment and PPAP reviews.

Skills

QA

Supplier QA

GMP

PPAP

Auditing

Education

Bachelor degree

Job description

• Responsibilities may include the following and other duties may be assigned.
• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards through supplier assessments, process validation reviews, and evaluation of Production Part Approval Process (PPAP) documentation.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include:
• Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow to provide customers with the highest quality and reliable products.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
• Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
• Define Receiving Inspection requirements as required and associated test method validation for all internal Test Methods.
• Supports supplier change management activities including manufacturing site transfers, process changes, equipment changes, and material changes through risk assessment, supplier audits, PPAP review, and requalification activities.

Summary

• Responsibilities may include the following and other duties may be assigned.
• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards through supplier assessments, process validation reviews, and evaluation of Production Part Approval Process (PPAP) documentation.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include:
• Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow to provide customers with the highest quality and reliable products.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
• Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
• Define Receiving Inspection requirements as required and associated test method validation for all internal Test Methods.
• Supports supplier change management activities including manufacturing site transfers, process changes, equipment changes, and material changes through risk assessment, supplier audits, PPAP review, and requalification activities.

Roles & Responsibilities

• Responsibilities may include the following and other duties may be assigned.
• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards through supplier assessments, process validation reviews, and evaluation of Production Part Approval Process (PPAP) documentation.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include:
• Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow to provide customers with the highest quality and reliable products.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
• Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
• Define Receiving Inspection requirements as required and associated test method validation for all internal Test Methods.
• Supports supplier change management activities including manufacturing site transfers, process changes, equipment changes, and material changes through risk assessment, supplier audits, PPAP review, and requalification activities.

Requirements

• Bachelor degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R.
• 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.