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Supplier Quality Engineer
Job Opportunity at
Kyler Professional Search
Posted on Sep 13
Salt Lake City,
Job Summary / Function:
This position is responsible for supporting the compliance activities to all applicable Federal, State and local regulations pertaining to GMP/QSR, ISO and associated regulatory agencies. Assists with the implementation and improvement of all aspects of Quality System. This includes all organizational excellence processes, quality improvement and compliance efforts for products / processes assigned by Quality Manager.
Primary Duties and Responsibilities:
· Primary support for the Supplier Management process by working closely with Supply Chain, Manufacturing, and R&D to ensure suppliers meet specifications and other requirements.
· Works with suppliers and internal stakeholders to ensure potential suppliers for development projects meet requirements for qualification.
· Review new supplier requests for impact on quality system
· Lead and conduct Quarterly Supplier Reviews (metrics/trends)
· Maintain procedures, supplier records, and Approved Supplier List
· Major participant in risk analysis activities as they relate to suppliers
· Conduct Supplier site evaluations with travel up to 20%
Secondary Duties and Responsibilities:
Support all functions surrounding/ensuring product quality for items assigned.
· Partner with customers to provide exceptional service and attention to their needs in a timely and professional manner
· Represent Quality on product teams
· Assure customer change requests are viable and communicated to the appropriate departments
· Communicate with internal and external customers and suppliers to resolve issues
· Assist with new product releases to assure they are accomplished timely and within all compliance standards
· Assist in the development of proper inspection and disposition systems of product/components
· Provide support in the deployment / maintenance and improvement of quality systems Create and implement document changes through PLM system
· Serve as SME to organization on PLM system
Participate in compliance and continuous improvement of manufacturing processes
· Assist with the implementation of quality management strategies and plans that assure the highest level of quality is met while maintaining deadlines and budgets
· Develop and implement process monitoring, where appropriate
· Conduct process audits
· Develop / Review applicable process documentation – IQ/OQ/PQ
· Assist with equipment calibration and audit equipment preventive maintenance
Develop product quality plans which includes sampling plans, test methods and procedures to support new and existing product lines
Assist with initiatives in continuous improvement and organizational excellence using suitable lean, six sigma and/or other alternate approaches
Participate in Product Development activities
· Approve and support design and process verification and validation protocols
· Approve and support software verification and validation protocols
· Develop component and product inspection criteria for assigned products
· Assist with qualification and auditing of suppliers
· Ensure product compliance to standards during development
· Create and execute Risk Management Plans and Risk Assessment activities according to ISO 14971 and internal procedures
· QA representative on design reviews
· Support implementation, maintenance and operation of an effective Corrective and Preventative Action (CAPA) system. Proficient use of root cause analysis tools such as Fishbone, 5-why, etc.
· Support implementation, maintenance and operation of an effective Non-conforming (NCR) material program.
· Support Calibration system efforts
· Support Quality Manager in reporting on the performance of company quality metrics and corrective and preventative actions.
· Complete all assigned CAPA, NCR and other tasks in a timely manner.
· Ability to lead cross functional teams
· Create training documents and complete required training in a timely manner
· Assist in the development, implementation and attainment of “Key Performance Indicators” (KPI)
· BS degree in Mechanical Engineering or another STEM field
· Five or more years of experience with Supplier Quality Assurance Engineering or equivalent progressive experience in Quality Assurance or related field.
· Excellent written and verbal communication skills
· Demonstrated knowledge and execution of data analysis tools such as SPC and process capability studies
· Ability to rapidly acquire detailed knowledge of the specific systems
· Knowledge of QSR, ISO9001, ISO13485 regulations and lean manufacturing principles
· Personal drive and follow through, strong human relations and team building skills
· Able to succeed in highly regulated compliance oriented environment while still providing service excellence
· Experience with Quality Management Systems
· Strong computer knowledge, including Microsoft Office (Word, Excel, PowerPoint) and Minitab
· ASQ Certified Quality Engineer
· Green or Black Belt Six Sigma Certification
· IPC Certification
· Lead Auditor Certification
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