Sr Quality Engineer - Production Support
LifeCell Corporation - Branchburg, NJ

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Position Summary: 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. Primary Duties/Responsibilities: · 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 Qualifications Position Qualification Requirements Basic Qualifications · 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. Preferred Qualifications: 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.
LifeCell Corporation - 2 years ago - save job
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LifeCell Corporation's portfolio of products includes our well-known soft-tissue repair products for abdominal wall reconstruction, breast...