Quality Engineer
SeraCare - Milford, MA

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Responsible for providing Quality Engineering in support of the Quality Systems and production operations at SeraCare HQ facility. Provide intensive and diversified quality engineering support for products, processes, equipment and quality system data, while completing projects in broad areas of assignment. Basic responsibilities include: Quality/technical support & mentoring, training of employees, failure investigation, oversight/determination of disposition of nonconforming materials, conducting and updating risk analysis documentation and processes, defining/refining quality inspection plans, performing data collection and trending for presentation of key metrics, identifying and addressing supplier quality issues, reviewing and generating validation/protocol data, and optimizing and improving quality systems and documentation.

A Bachelor's Degree in Engineering or Science is required, along with 8+ years of experience in quality engineering. Strong interpersonal, organizational, verbal/written communication skills and the ability to work effectively as a team member is necessary. Pharma and/or Medical device experience or equivalent experience in a regulated industry. Experience handling deviations, investigation and CAPAs preferred. Demonstrated knowledge of 21 CFR 820 (Quality System Medical Devices) and 21 CFR 210, 211. Proven ability to work effectively in a team environment through conflict resolution and negotiations. Knowledge of statistical methodologies, quality control and manufacturing tools, such as applied statistics, lean manufacturing DMAIC, Six Sigma, etc. Demonstrated computer skills using spreadsheets, word processing, database and other applicable software programs including Statistical Process Control Experience with QMS software is highly desirable. ASQ Certified Quality Engineer certification is preferred.

SeraCare Life Sciences, Inc. is an Equal Opportunity Employer, M/F/D/V

SeraCare - 2 years ago - save job