Quality Engineering Manager - Holdrege, NE - On-site Full-time

 

About the job

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Job Description

• The Quality Engineering Manager will lead all Quality Engineering activities and incoming quality issues. Ensure all quality related systems of the plant are established and documented to provide a safe and effective product.
• Build sound technical and organizational competence within area of responsibility.
• Ensure the systems and products comply with applicable government regulations.
• Comply with all embecta quality policies, procedures, and practices through consistent application of sound quality engineering/assurance principles.

 Responsibilities:

• Evaluate, design, implement and improve a production and process control strategy to achieve quality management and plant objectives.
• Participate on material review board. Provide quality engineering support to product/process validation effort.
• Review and approve changes to the device master record.
• Review and approve qualifications and validation protocols and results.
• Develop and approve strategic quality planning.
• Provide appropriate oversight and direction to quality engineering projects. Support continuous improvement processes, i.e.: lean manufacturing, root cause determination, control plans and six sigma and statistical problem solving.
• Oversee the vendor qualification and certification programs in collaboration with supply management and supply quality engineer.
• Comply with all embecta quality policies, procedures, and practices through consistent application of sound quality assurance principles.
• Comply with all local, state, federal and embecta safety regulations, policies, and procedures.
• Provide effective quality engineering leadership in teamwork development, effective communication, and quick responses to customer needs.
• Build organization capability for quality engineering in the selection and mentoring of professionals.
• Build a strong interactive, working, and strategic relationship with embecta Holdrege manufacturing and Global quality management and other staff.
• Function as primary engineering respondent during FDA, ISO and other 3rd party audits and follow up on any action plans.
• Performs other duties as assigned by the manager and required to support the needs of the business.

 Basic Requirements:

• Bachelor's degree in engineering, Quality Assurance, Mathematics/Statistical or Science related field required.
• 3+ years in Medical Device Manufacturing, Validation, PFMEA.
• 1+ years management experience.
• Quality tools (MSA, TMV, Capability Analysis, PFMEA, Validation, 8D, 5Y.).
• Quality Systems.
• strong knowledge of statistical and sampling plans.

 Preferred Requirements:

• Master's degree desirable.
• Project Management.
• Six Sigma Desirable.
• Risk Management experience.
• Strong applicable knowledge on Statistical and Sampling Plans.
• Root Cause analysis principles.
• CAPA.

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