Quality Engineering Manager

Department: Clinton Support

Office: Clinton, MA
Location: Clinton, MA
Job Grade: MG1
GBU: HC
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Position Summary:

Plan, implement and direct all quality engineering efforts related to the qualification and validation of molds and assemblies to ensure customer satisfaction. Coordinates and plans all resources in providing required quality engineering services in the most efficient and competent manner. This position is also responsible for managing all activities associated with the inspection and acceptance of incoming receipts of purchased raw material and components, the calibration of all measuring, inspection and test instruments that are used to monitor critical product characteristics and process parameters, and the quality of parts produced for Nypro Clinton by outside contractors.

Education and/or Experience:

B.S. in a Technical or Applied Science discipline or equivalent, with 8 - 12 years quality engineering experience, and at least 5 years in a supervisory capacity.
Excellent communication and problem solving skills required. Must have the demonstrated ability to be an effective leader and possess good interpersonal skills. Must have a thorough understanding of statistical methodology relating to quality planning and analysis, Design of Experiments, quality problem solving tools, and applicable statutory and regulatory standards including ISO and cGMP.
Key Responsiblities:

* Plan, promote and participate in activities to support safety.
* Ensure complete compliance to all applicable statutory and regulatory standards including cGMP/QSR, ISO 9001 and ISO 14001.
* Develop and implement the strategic vision and tactical plan for Memoir Quality Engineering, Retrology/ Auto Inspection and Incoming Inspection departments that supports Nypro Clinton goals and objectives.
* Plan and direct the effectiveness of incoming inspection services including ensuring that the acceptance criteria for each raw material or purchased component affecting product quality have been documented in Incoming Inspection History Cards, that the conforming product is released to material stores in a timely manner, that the nonconforming material is identified, quarantined and controlled using the NCMR process, and that the defined calibration program is executed per applicable work instructions.
* Act as a change agent and participate in activities that focus Nypro Clinton on improving customer focus, process planning and improvement, and employee empowerment.
* Prepare and monitor overall budget performance for responsible departments. Serve as a member of the Quality Steering Committee.
* Develop and implement strategies to ensure positive employee relations and effective communication.
* Provide support and guidance to the management staff in areas of staffing, performance appraisal and disciplinary actions.

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