Supplier Quality Engineer

Planet Pharma; El Paso (TX); On-site; USD 70,000 - 110,000; Full time

Job summary

Planet Pharma is seeking a Supplier Quality professional to qualify suppliers, monitor performance, and ensure adherence to quality systems throughout the product lifecycle. The role collaborates with R&D, sourcing, engineering, operations, and quality to deliver high-quality, reliable components and materials.

The ideal candidate has experience in Medical Device or automotive qualification, knowledge of ISO 13485 and FDA QMSR, and familiarity with Agile project management and TrackWise.

Qualifications

• Experience in Medical Device Industry or automotive part qualification.
• Knowledge of ISO 13485 and FDA QMSR.
• Experience with Agile project management is a plus.

Responsibilities

• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection.
• Monitors supplier performance and resolves supplier-related problems during the manufacturing cycle.
• Provides technical guidance and ensures quality compliance throughout the product lifecycle, focusing on supplier changes.
• Collaborates with cross-functional teams (R&D, sourcing, engineering, operations, quality) to ensure high-quality, reliable products.

Skills

Supplier Quality

Quality Assurance

Regulatory Knowledge

Project Management

Agile

Education

Bachelor's degree

Advanced degree

Tools

TrackWise

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 and may administer a Certified Supplier
  Program in receiving inspection to ensure cost effectiveness.
• Motitors parts from acquisition through the manufacturing cycle and communicates and
  resolves supplier-related problems as they occur.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback
  in assessment of their operation.
• Partners with cross functional teams (R&D, sourcing, engineering, operations, quality), to deliver
  quality parts, materials, and services, prevent defects, and allow the company to provide customers
  with the highest quality and reliable products.
• Provides technical guidance and quality compliance throughout the product lifecycle (with focus
  on supplier changes) 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 cross functional teams 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.

• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• Bachelors 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)
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
• Demonstrated experience on Medical Device Industry or Automotive part qualification requirements
• May have practical knowledge of project management.
• Experience using Agile and Trackwise would be a plus
• Knowledge of ISO 13485 requirements
• FDA QMSR
• Geometric Tolerances
• Supplier Development, quality and process improvement