2018-09-13

Supplier Quality Engineer
Job Opportunity at Kyler Professional Search

Posted on Sep 13

http://www.kylerprofessionalsearch.com    412-420-0061

Location: Salt Lake City, UT
Job Type: Full Time
Job ID: W4167526

 

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:

Supplier Quality

·        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
 
Quality Systems
·        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.

 

Miscellaneous

·      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)
 

Minimum Qualifications:

·      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
 

Preferred Qualifications:

·      ASQ Certified Quality Engineer
·      Green or Black Belt Six Sigma Certification
·      IPC Certification
·      Lead Auditor Certification
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