Sr Supplier Qual Engineer

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PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. PharmaLex offers professional development, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.

JOB DESCRIPTION

• Support the evaluation, selection and qualification of global best-in-class components suppliers and CM/OEM supplier through the application of appropriate tools and measurements
• Partner with multiple functions, including Supplier Quality, Design Engineering, Manufacturing, Quality, Reliability and Regulatory to evaluate, select and approve component or materials for active projects.
• Partner with suppliers to ensure components / materials / sub-assemblies are qualified and validated to the appropriate requirements prior to commercialization.
• Supplier Selection and Continuous improvement
• Own process validation, component qualification
• Develop test method validations
• Develop product acceptance, determine proper inspection plan and procedures.
• Develop a strong relationship with the Suppliers.
• Prepare and negotiate Quality Agreements with suppliers
• Apply process development and materials knowledge to component development and quality issues
• Review supplier processes and equipment for optimum output, yield and process stability
• Represent the organization as the primary supplier/OEM technical contact, at times requiring coordination between organizations
• Review and approve changes to Medtronic specifications for purchased materials used in production and manage the supplier change execution process with the supplier in partnership with Sourcing Engineering.
• Develop and maintain controls and qualification plans and reports to assure components, materials and suppliers meet specified requirements and performance, reliability goals
• Review and approve supplier change requests and partner with Sourcing Engineering to develop and implement appropriate strategies to qualify and support the change approval process
• Develop technical solutions to complex problems using the corrective/preventative action process
• Analyze and identify trends from quality data and develop proactive measures with suppliers in support of continuous improvement
• Work with Tier 1 Suppliers to ensure adequate controls exist on sub-tier suppliers and that appropriate monitoring is established by the Tier 1 suppliers
• Lead or participate in supplier audit/assessment of current or future suppliers, ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements
• Maintain approved supplier files
• Understand and operate to medical device regulatory guidelines (GMP, FDA, ISO13485) and company Quality System procedures
• Provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, and practicable, and consistent with organization objectives

  What are the top 3 things you are looking for in a candidates experience:

1. Supplier quality knowledge, to Partner with suppliers to ensure components / materials / sub-assemblies are qualified and validated to the appropriate requirements prior to commercialization.
2. Develop product acceptance, determine proper inspection plan and procedures.
3. Develop technical solutions to complex problems using the corrective/preventative action process. Analyze and identify trends from quality data

  Education Required:

Bachelor degree of Engineering
4+ years of experience in supplier quality engineering.

 Nice to Have

4+ years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise.

 PharmaLex is an Equal Opportunity Employer.