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ATR International

Senior Supplier Quality Engineer

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Job Description

Senior Supplier Quality Engineer ATR International - 3.8 Louisville, CO Job Details Contract $50 - $65 an hour 1 day ago Benefits Health insurance Dental insurance 401(k) Vision insurance Qualifications Teamwork Supplier corrective action implementation New product development Preventive action implementation Quality control preventive actions Corrective and preventive actions (CAPA) GMP Master's degree Bachelor's degree Leading team collaboration initiatives Project leadership Cross-functional team management Cross-functional communication Full Job Description Sponsorship for employment visas is NOT available for this position (e.g., H-1B, OPT/CPT stem extensions, STEM OPT extension). Applicants must be currently authorized to work in the United States on a full-time basis.
Location:
Louisville, CO 80027
Employment Type:
6-month contract Pay range: $50-65/hour
Company Overview:
Our client is a global leader in medical technology that researches, designs, and manufactures healthcare devices.
Position Summary:
The Senior Supplier Quality Engineer plays a critical role in ensuring product quality, safety, and regulatory compliance throughout the medical device product lifecycle, with a primary focus on product design, development, and sustaining engineering. As the supplier quality representative on cross-functional project teams, you will provide technical leadership in supplier controls, risk management, verification and validation, and quality system compliance, partnering closely with Research & Development, Manufacturing, Regulatory Affairs, and Supply Chain to deliver safe, effective, and compliant medical technologies.
Key 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. 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 Client 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.
Qualifications:
Requires a Baccalaureate degree AND minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience
Technical Skills Required:
1. Experience supporting new product development (NPD) or design transfer to suppliers. 2. Strong analytical, collaboration, communication, and influencing skills, with the ability to lead cross-functional teams and drive quality decisions without direct authority. 3. Partner with cross-functional teams to support supplier changes, nonconformances, and CAPA activities. #IND3
Pay:
$50.00 - $65.00 per hour
Benefits:
401(k) Dental insurance Health insurance Vision insurance
Work Location:
In person

Benefits

  • 401(k) Plans
  • Health Insurance
  • Dental Insurance
  • Vision Insurance