Essential Job Functions include
- Ensure processes complies with the tolerances stated on the product specification and drawings QSR and ISO standards.
- Support product development activities i.e. DFMEA, PFMEA, PCP, PVP, TMV, and validation protocol reports IQ, OQ, PQ.
- Lead cross functional teams to improve process and product understanding.
- Act as main interface for all customer quality requirements for specific devices and responsible for meeting requirements.
- Assist in determination and implementation of test and inspection activities required for quality inspection.
- Investigate and analyze manufacturing, customer, and supplier problems.
- Resolve customer quality issues by executing Corrective Action Preventive Action (CAPA) processes.
- Use Lean Six Sigma methodology and quality engineering tools to achieve continuous improvement.
- Implements process improvements including fixtures, tooling, production checks, testing/inspection devices.
- Establish mechanism to evaluate, measure, monitor and/or quality in our products to improve efficiency of the production process.
- Assist in trouble shooting in manufacturing, and engineering activities.
- Review and approve product design.
- Participate in internal/external audits to ensure the effective implementation of Quality Management System (QMS).
- B.S. Degree in Mechanical Engineering or other Science related field
- Minimum 5 years’ experience in QE capacity engineering in a manufacturing environment; preferably in a medical or pharmaceutical environment
- CQE preferred
- Working experience with the application of statistical methods in quality assurance systems and processes
- Six Sigma Green Belt Certification preferred
- Strong written and oral communication skills
- Excellent organizational and interpersonal skills
- Ability to work effectively in a team environment
- Knowledge of 21 CRF 820 and cGMP’s
- Ability to develop sound and simple systems to assure ISO and regulatory compliance
- Provide recommendations based on business system results
- Well-developed verbal, numerical reasoning and analysis sills with ability to draw sound conclusions
- Ability to interact with operations management at all levels
- Ability to take initiative; completion of tasks in an accurate and timely manner; attention to detail