The posting
In This Position, You Will Have the Opportunity To:
Serve as the Quality Management Representative (QMR) for the manufacturing facility, including hosting third party audits and inspections, organizing and conducting periodic Management Reviews of the Quality System Carry out leadership responsibilities in accordance with the organization’s policies and applicable laws which includes interviewing, hiring, developing and training employees; planning, assigning, and directing work; appraising performance; rewarding and coaching employees; addressing complaints and resolving problems Ensure all required investigations (i.e. complaints, NCs) are robust, thorough, and completed in a timely manner Champion and lead continuous improvement, VIP, and standard work efforts Chair the site’s Corrective Action Board (CAB) and drive the CAPA program by ensuring opportunities are well documented, timelines are adhered to and status is reported to management on a routine basis Oversee activities associated with calibration of Inspection, Measure, and Test Equipment (IM&TE) including standards, recall, review/approval of records, and out of tolerance investigations Lead, maintain and create efficiencies in the Quality Management System to fulfill both domestic and international quality system requirements (e.g. FDA’s QMSR, ISO 13485, and other international standards) Host FDA/ISO and other regulatory agencies or customers for audits Support product integrations associated with acquisitions and new product development Ensure the effective maintenance of Device History Records, and other quality documents Manage the internal audit program including training internal auditors, creating and maintaining internal audit schedules, assuring internal audits are performed and completed according to approved schedule Monitor the health and well-being of the QMS through quality trending, analytics and established KPIs
What You Need to Succeed in This Position
Bachelor’s Degree in Engineering or a related technical discipline such as, Chemistry or Biology or equivalent combination of education and experience A minimum of 5-8 years of quality assurance experience in a medical device, pharmaceutical, or regulated manufacturing environment. A minimum of 1-3 years’ experience managing quality team members. Industry or discipline specific certification a plus (CQE, CQA, CMQ/OE, Lean, Six Sigma, etc) Experience in chemical mixing, liquid formulation, or filling operations preferred. Displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levels Ability to make effective decisions and maintain effectiveness under changing circumstances and priorities Teamwork, communication, positive attitude required to support the manufacturing environment Extensive experience in problem solving – able to perform root cause analysis and implement effective corrective actions Able to effectively manage and complete multiple projects simultaneously Excellent computer skills including but not limited to Microsoft Office Suite
Knowledge of quality systems including the quality manual, quality policy and applicable procedures and work instructions Ability to support the establishment, implementation, and maintenance of the quality system in accordance to FDA Quality Management System Regulation, ISO 13485, and European Union Medical Device Directives.
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