Supplier Quality Engineer: Drive Quality & Compliance

Katalyst-Healthcares-; Lafayette (CO); On-site; USD 85,000 - 115,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Supplier Quality Engineer to lead pre-market quality activities for new products with cross-functional teams in Colorado.

You will qualify suppliers, manage PPAP documentation, and ensure GMP and quality standards across the supply base while supporting NPD stages and supplier change management.

Qualifications

• Bachelor's degree or higher with 4 years of relevant experience, or 2 years with advanced degree.
• Experience in supplier quality engineering and GMP standards.

Responsibilities

• Qualifies suppliers per company standards via assessments and PPAP documentation.
• Develops auditing schedules to ensure GMP and quality standards are met.
• Provides QA support across NPD lifecycle and collaborates with Component Engineers.
• Defines Receiving Inspection requirements and test method validation.
• Supports supplier change management including PPAP reviews and requalification.

Skills

Supplier Quality Engineering

Pre-Market QC

PPAP

GMP compliance

NPD collaboration

Education

Bachelor's degree in engineering or related field

Tools

PPAP documentation

Quality systems

Job description

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.

Roles & Responsibilities :

• 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.