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Quality Assurance Engineer Jobs in Delaware

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Job Title: Manufacturing Quality Engineer for small to mid size biotechnology company, located in Newark, DE
Company: Strategic Diagnostics
Location: Newark, DE

Description:
Job Responsibilities:Utilize professional scientific expertise to provide leadership in the technical production efforts of the company. Responsible for ensuring products meet marketed requirements through the use of quality engineering programs and techniques. Exercises initiative to address and take responsibility for issues that have broad/long-term technical impact. Contribute to the advancement of company goals and objectives. Educate, inform, and guide other professionals on staff. Responsibilities and Duties:* Ensure that developed and marketed products comply with quality and engineering requirements * Establish appropriate release tests based on customer applications* Provide quality engineering support to the Product Development Core Team * Work closely with R&D, Marketing and Quality Assurance to develop and implement appropriate risk management, qualification, verification and validation plans * Orchestrate manufacturing validation and post commercial launch activities* Foster quality control testing program, including stability testing program and lot to lot variability* Provide guidance in the assessment of suppliers and work with purchasing to resolve quality issues with suppliers * Lead problem-solving efforts to identify and resolve new and recurring quality issues * Foster continuous improvement by proactively reducing variation and eliminating defects using SPC tools* Act as the liaison on quality issues with the customer* Ensure the resolution of issues raised by testing and customers* Develop, implement, manage and track effectiveness of corrective action plans and compliance improvement initiatives * Ensure accurate project schedules are maintained and communicated to both internal and external management * Perform statistical analysis of data and writes technical reports




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