Sr Supplier Quality Engineer

Katalyst HealthCares and Life Sciences

$90K — $115K *
Manufacturing & Automotive
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Baccalaureate degree with 4+ years relevant experience or Master's degree with 2+ years
  • Experience in new product development (NPD) and design transfer to suppliers
  • Strong analytical and collaboration skills
  • Excellent communication and influencing abilities
  • Capacity to lead cross-functional teams without direct authority

Responsibilities

  • Ensure suppliers deliver quality parts, materials, and services
  • Monitor parts from acquisition through manufacturing and resolve supplier-related issues
  • Develop and prioritize auditing schedules for suppliers to maintain GMP and quality standards
  • Evaluate suppliers' performance and provide operational feedback
  • Support Pre-Market Quality Engineering for NPD, preventing defects and ensuring high product quality
  • Deliver quality compliance and technical guidance for supplier quality across NPD lifecycle
  • Collaborate with Component Engineers on Product Acceptance Sampling Strategy and Quality Control Plans

Benefits

  • Comprehensive health and wellness programs
  • Opportunities for professional development and training
  • Flexible work arrangements
  • Supportive company culture focused on quality and innovation
  • Engagement in impactful projects within the healthcare sector
Full Job Description
Roles and Responsibilities :
  • 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.
  • 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.
  • 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 Healthcare 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 Healthcare Test Methods.
Education and Experience:
  • Requires a Baccalaureate degree AND minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience
  • Experience supporting new product development (NPD) or design transfer to suppliers.
  • Strong analytical, collaboration, communication, and influencing skills, with the ability to lead cross-functional teams and drive quality decisions without direct authority.
  • Partner with cross-functional teams to support supplier changes, nonconformances, and CAPA activities.

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