Quality Engineer

Job Details

Description

Duties and Responsibilities (essential duties are italicized)

• Support to manufacturing processes in a daily basis, by allocating enough inspection and investigation support as needed.
• Support design control and process validation activities for new and existing product change efforts.
• Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sampling plans.
• Support the Non-Conformance Report (NCR) process and system for the sites.
• Responsible for the data analysis and reporting for the sites and identify quality issues. Responsible for reporting NCR scorecard results to appropriate site management.
• Identified quality issues are considered appropriated for immediate resolution and work effectively to ensure that these are escalated to CAPA accordingly.
• Maintain regular interface with site management to achieve company goals and escalate any issue related to NCR in terms of trend, resolution or resolution regarding NCR process.
• Support as needed in projects associated with NCR process and application for the sites and processes.
• Establish and report NC dashboard/metric against base business performance to management,
• Develop and implement measures to monitor the effectiveness of the NCR process
• Participate as requires in Audits and Management Reviews
• Lead the weekly Daily Quality updates at GEMBA meeting.
• Lead/ participate in quality systems and compliance improvements that results from Internal/External Audits, management Reviews and any other NCR/CAPA system indicators.
• Provide support to CAPA leader in the preparation of Data Review Board, CAPA and the administration of the system.
• Support all internal external audit or assessment to the site.
  
  

Minimum Knowledge, Skills, And Abilities Required

• A minimum of a bachelor’s degree in engineering, Life Science, Physical Science or a related
  
  

field is required; an advanced degree is an asset.

• Bachelor’s degree is required. Concentration in Engineering and/or Scientific discipline
  
  

preferred.

• A minimum of 2 years of expertise in Quality System Regulations is required.
• Manual and semiautomated Manufacturing process support experience.
• Solid experience in problem solving and failure investigations techniques.
• Must have experience with CAPA, Complaints, Quality Operation, Change Management.
• Experience working in a regulated industry is preferred.
• Strong knowledge and experience in process validation principles
• Experience in computerized Quality Information System is preferred.
• Project management and influencing skills are required.
• Demonstrated ability in communication, negotiation and presentation skills required.
• Must have the capability to plan, coordinate, organized, compile, analyze, evaluate, negotiate
  
  

and calculate.

• Ability to drive timely decisions with minimal data required.
• An ASQ certification (CQE, CQM, CRE or CQA) is an asset.
• Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
• Advanced computer skills and use of software application is required.
• Good communication and presentation skills will be needed.
• Apply appropriate Quality Engineering and PEx tools (e.g. DMAIC, FMEA/FTA, RCA, MSA, SPC,
  
  

Cp/Cpk/Cpm/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP, etc.) to support innovations and continuous

improvements

• Comply with all applicable quality management system, environmental, safety and occupational
  
  

health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).

This position is onsite in McKinney, TX with possible travel to Arlington, TX. This position pays $80,000-$90,000

Annual Bonus potential of 7.5%