Principal Engineer - Quality Supplier

29 Apr 2024

Vacancy expired!

Summary: Participate, support, and lead activities related to suppliers of raw material, components, finished devices and services for the inspection of incoming materials, implementation of corrective/preventive actions, validations, certifications, qualifications and any project related to quality improvement.

Essential Functions & Responsibilities:
  • Work directly with suppliers to ensure that the product or service received meets requirements and specifications.
  • Responsible for generating quality standards and maintaining current standards.
  • Develop and implement improvement programs for suppliers.
  • Attend and participate in quality metric reviews.
  • Responsible for generating corrective and preventive actions to suppliers, and verification of the effectiveness of such actions for approval and closure.
  • Responsible for follow ups, implementation and closure of corrective and preventive actions either internal or external.
  • Collect and distribute supplier performance data.
  • Support suppliers on the implementation of improvement plans ( example SPC, Gage R&R, etc)
  • Support and lead initiatives to improve supplier’s performance in order to certify them or reduce receiving inspection activities.
  • Participate in the analysis of complaints related to suppliers.
  • Participate in different projects like Kaizen, PE (GB/BB) and lean.
  • Interact with other groups for the process of supplier selection.
  • Support other groups of the company on any quality issues related to suppliers.
  • Support the Quality Audit group providing quality metrics and supplier performance data.
  • Participate and support the introduction of new products in relation to new components or finished devices provided by suppliers.
  • Responsible for the generation or updates to Supplier Quality Agreements.
  • Participate and support activities related to changes requested by suppliers or initiated by Cordis involving suppliers.
  • Participate in the investigation process and risk analysis of non-conformances caused by suppliers.
  • Complete all training on time assigned by the quality compliance department.
  • Responsible for approving and/or escalating deviations on product specifications or processes from suppliers.
  • Responsible to review, create and approve changes to procedures, work instructions, forms, specifications, inspection reports and other related controlled documentation.
  • Support receiving inspection group to take actions when a nonconformance is received.
  • Visit and evaluate suppliers thru audits or technical assessments.
  • Responsible for communicating business related issues or opportunities to next management level
  • For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets
  • Performs other duties assigned as needed

Education & Experience Requirements:
  • Bachelor degree in an engineering discipline
  • Professional experience of 7 to 10 years with activities described in the previous section
  • 5 Years of experience in Quality Assurance working with suppliers
  • Understands corrective and preventive action systems (CAPA)
  • Understands statistical analysis techniques
  • Understands GMP, QSR, MDR, ISO 13485 requirements
  • Experienced with validation, certification and auditing of suppliers
  • Understands specification drawings and departmental procedures
  • Knowledge of document control systems, preferably ADAPTIV and JDE
  • Understands six sigma tools, preferably Green Belt certified or higher
  • Works under minimum supervision and takes self-directed action
  • Ability to negotiate and mentor other engineers
  • Ability to take actions as needed based on Cordis
  • Ability to develop and implement quality standards
  • Understands business principles
  • Able to travel
  • Able to work extra time based on requirements
  • Effective verbal and written communication skills
  • Proficient at speaking, writing and understanding English
  • ASQ certified in Quality Engineering is preferred

#LI-VC1

  • ID: #39826925
  • State: Florida Miamigardens 00000 Miamigardens USA
  • City: Miamigardens
  • Salary: TBD
  • Job type: Full Time
  • Showed: 2022-04-29
  • Deadline: 2022-06-27
  • Category: Et cetera