Quality Manager

Company : Katalyst Healthcares & Life Sciences

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 the client 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 the client quality policies, procedures, and practices through consistent application of sound quality assurance principles.
• Comply with all local, state, federal and the client 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 the client 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.

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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