Supplier Quality Engineer

1 day ago

Ball Ground, GA, United States CAIRE Inc Full time
Summary/Objective

The Supplier Quality Engineer follows end to end quality from raw materials to finish goods ensuring supplier quality is managed throughout, while maintaining ISO, FDA and MDSAP standards. The Supplier Quality Engineer will work directly with suppliers, operations personnel, quality engineers, product engineers, quality technicians and machinists to improve and sustain supplier quality.

The Supplier Quality Engineer will manage supplier quality by performing the following: evaluation of new or existing suppliers through the utilization of PPAP's, using lean six sigma methodology to improve a supplier's manufacturing processes, conducting supplier audits, and lastly managing the dispositioning of supplier quality issues through CAIRE's SCAR and NCR program. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Develop and maintain supplier quality relationships while implementing supplier improvement to mitigate risk to CAIRE at a Global Level.
  • Assist with the continuous improvement and sustainability of CAIRE's Supplier Quality Program.
  • As part of CAIRE's supplier evaluation and qualification process, conduct PPAPs that include methods such as MSA's, correlation studies, PFMEA's, manufacturing control plans, etc., to ensure the establishment of quality approved products before they are received by CAIRE's manufacturing facilities.
  • Utilizing experience related to different manufacturing processes such as injection molding, die casting, PCBA manufacturing, deep drawing, stamping, CNC machining, etc., visit supplier locations to assist in the resolution of quality problems.
  • Utilizing lean six sigma methodology, investigate supplier quality issues to identify opportunities for improvement as well as assisting suppliers on implementation of those improvements.
  • Assist with supplier audits and facilitate pre-assessments and self-surveys.
  • Manage SCAR's, NCR's and participate in/lead CAPA's.
  • Lead/own quality projects related to supplier part defects, cost down initiatives and risk reduction.
  • Develop and document work instructions, procedures, quality alerts, within the incoming inspection process.
  • Other duties and responsibilities as assigned.
Competencies/Success Factors
  • Mechanical Skills
  • Detail Orientation/Quality Focus
  • Adaptability/Flexibility
  • Time Management
  • Ethics, Integrity, Values
  • Customer Focus
  • Coaching/Developing others
  • Decision Making
Supervisory Responsibility
This position has no supervisory responsibilities

Work Environment
This job operates in a Manufacturing environment. While performing the duties of this job, the employee is regularly required to stand, walk, sit and occasionally stoop, kneel or crouch. Travel is required in this position.

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling.
  • Occasional lifting up to 30 lbs., occasional heavier lifting.
  • Occasional pushing, pulling and handling of materials.
Travel
This position requires up to 25% travel. Some of the travel is international.

Required Education and Experience
  • Minimum B.S. degree in engineering or other technical discipline and minimum 5 years of relevant experience.
  • Extensive knowledge and experience in different manufacturing processes such as: injection molding, die casting, PCBA manufacturing, deep drawing, stamping, CNC machining, etc.
  • Extensive knowledge and experience in PPAP's and all methods associated with PPAPs such as: MSA's, correlation studies, PFEMA's, manufacturing control plans, etc.
  • Experience in product quality related data analytics tools such as process capabilities, SPC, pareto, I-MRs, etc.
  • Experience in different software solutions such as: Minitab, Tableau, Solidworks, InfinityQS or other SPC software solutions, MasterControl or other EQMS software solutions.
  • Experience with FDA-regulated businesses & ISO 13485 and or 9001 Quality Systems practices.
  • Certified greenbelt or blackbelt in Lean Six Sigma, preferred.
  • Certified Quality Engineer (CQE) and/or Certified Supplier Quality Professional (CSQP) and Certified Quality Auditor (CQA).
Preferred Education and Experience
  • 5yrs experience in the Medical industry.
  • 2-3 years of related experience
  • Bachelor's degree in related field

Additional Eligibility Qualifications
None required for this position.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

CAIRE is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

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