Quality Engineering Manager
Quality Engineering Manager
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Salary Not Disclosed
1 Vacancy
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.
- 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.
- Bachelors 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.
- Masters degree desirable.
- Project Management.
- Six Sigma Desirable.
- Risk Management experience.
- Strong applicable knowledge on Statistical and Sampling Plans.
- Root Cause analysis principles.
- CAPA.
Employment Type
Full Time
