Quality Engineer II

PRIMARY PURPOSE SUMMARY

DETAILED DESCRIPTION

Primary Duties & Responsibilities

• Participate in New Product initiatives and develop customer specifications.
• Manage product holds, creating sampling plans, and disposition instructions.
• Manage COAs for product shipments.
• Perform Bioburden and Environmental monitoring sampling.
• Create customer relationships for Quality related functions (complaints, defect reporting, quarterly visits). Manage customer complaints to resolution.
• Manage customer complaints via ETQ Reliance.
• Support Quality Lab equipment: CMM, Force gauges, calipers, micrometers, etc.
• Create Sample request for new products or change requests.
• Participate and lead Reselection/Rework initiatives.
• Coordinate with Regulatory groups for customer requests, and where applicable, use TraceGains.
• Suggest, lead, and participate in Continuous Improvement projects (QRQCs).
• Complete end-of-month budgetary reporting for internal and customer accruals related to Quality.
• Support Document Control & Monitoring and Calibration equipment initiatives.
• Support departmental annual objectives.
• Facilitate and lead on-site customer audits.
• Participates in regular one-on-ones, task delegation, coaching/mentoring programs, and constructive feedback methodologies.
• Support and lead PFMEA, MSA, PPAP, SPC, & DOEs.
• Suggests opportunities for system improvement and works as a team to drive improvements.
• Support and adhere to all system procedures and Company policies / procedures. Maintain a clean and safe work environment. Follow all safety regulations.
• Participate in other tasks as assigned

Qualifications

Education

• BS degree in Engineering, Quality Management, Business Administration preferred or equivalent experience and relevant certifications
• ASQ CSSBB, CQE, CQM/OE preferred

Experience

• 5 years’ of experience as a Quality, Manufacturing or Industrial Engineer is preferred but less than 5 may be considered based on other relevant experiance and/or education/certifications.
• High proficiency in computer technology and systems operation, experience with SAP, Minitab, Microsoft Suite (Excel, Word, PowerPoint) required
• Experience interacting with customers via phone, email, and face to face preferred
• Working knowledge of the ISO:9000 and SQF standards and requirements preferred, some knowledge required
• Black or Green Belt/Six Sigma certified and experience in continuous improvement activities such as Kaizen preferred

Skills

• Experience with developing and presenting a "story" regarding a defect (timelines, events, notes) which clearly communicates the issues to Management and others.
• Extensive experience in a quality assurance environment preferred
• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills.
• Broad skill set in customer negotiation preferred
• Ability to motivate and lead improvement in areas of responsibility
• Working knowledge of Root Cause investigation utilizing Quality tools, 5 Why, Ishikawa diagram, DMAIC, statistical analysis.
• Ability to build and maintain relationships in a manufacturing environment.
• Ability to work independently, resolve conflicts and drive customer satisfaction. 
• Professional and optimistic attitude, ability to work in a team environment.

Overview of Competencies by Cluster

• ISO Lead Auditor
• SQF and HACCP Lead Auditor
• Capable of setting up and running DOE’s
• ASQC Certified Quality Engineer
• Effective written, verbal, and sales presentation skills 

Authority Limits

• Budget Approval Amount
• Legal

Other Requirements

• Travel as necessary (up to 25%).
• Travel:             Frequent:             Sometimes: Yes             Never: