The Senior Quality Engineer is responsible for
· Assessing quality effectiveness via auditing and validations of systems
· Ensuring consistency of system/practices across product lines
· Fostering compliance and continuous quality improvements to meet and exceed customer expectations in regulated environment using validation/qualification, communication, motivation, assessment, and education.
· Assess effectiveness via auditing and validations of systems with respect to all relevant guidance, rules, regulations and requirements.
· Ensuring consistency of system/practices across product lines and their conformance to other industry practices.
· Ensure compliance to all LifeCell Corporation Design Control requirements by supporting Research and Development during the design of new products
· Perform follow-up and support to appropriate teams to ensure adequate corrective actions are documented, implemented and measured for effectiveness.
· Support in the development of proper specifications for equipment and process through validations and/or qualification.
· Act as internal consultant to the various departments and teams of LifeCell Corporation for current interpretation of GMP/ISO/QSR.
· Support the Risk Management process throughout all quality system elements such as Design Control Complaints, Recalls, etc.
· Perform quality investigations in support of various quality system elements such as CAPA/QI, Complaints, Non-conformances, etc.
· Participate in development of a strategic plan for LifeCell corporation quality system. Proactively work/motivate and guide facility teams to ensure corrective action efforts address root cause and result in effective quality systems. Reduce complexity of systems and make them more user-friendly for effective deployment.
· Assess and identify gaps in the employee training programs and interact with Human Resources to develop and implement training in: the logic and requirements behind our systems, the regulatory requirements for various job functions within LifeCell Corporation, quality tools (i.e., validations), and audit techniques.
· Ensure measurement of internal systems for effectiveness and schedule and implement status updates to staff members in a timely fashion.
· Compare quality system within LifeCell Corporation with other external sources to identify areas for improvement (i.e., benchmark).
· Support the completion of Continuous product/Process Improvement projects for identified areas throughout LifeCell Corporation through the use of Six Sigma/Lean tools
Position Qualification Requirements
· Bachelors in Quality Engineering or related field
· At least 7 years experience in quality engineering in a pharma/medical device industry
· Experience with Microsoft Office Applications including Word, Excel, and Outlook
Other Position Qualifications
In addition to the basic qualifications listed above, the following other position qualifications are required:
· Experience fostering compliance and continuous quality improvements using validation
· Experience validating and auditing systems and ensuring consistency of systems/practices
· Experience with quality investigations
· Experience with training compliance and quality improvement
· Demonstrated presentation and communication skills
· Knowledge of FDA Good Manufacturing Practices, ISO 9001 and ISO 13485 standards, LifeCell corporation policies and procedures, FDA's guidance on Validations, 93/42 EEC Medical Device Directive, and other applicable standards.
In addition to the basic qualifications and other required qualifications listed above, the following preferred qualifications also exist:
· Masters in Quality Engineering or related field
· Experience in statistics
· Certified Quality Engineer (CQE)
· Certified Quality Auditor (CQA)
The information listed in this Job Description is not a comprehensive list of all duties/responsibilities performed.
This Job Description is not an employment agreement or contract. Management has the exclusive right to alter this position guide at any time without notice.
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