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Job #03587

About our client Our client is a leading testing services firm that has developed a deep competency in the medical device sector. The company has a long history of success and has been growing steadily due to the efforts of an experienced management team. This is a great opportunity for the right candidate! Position Location Quality Assurance Manager California Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage GLP/GMP Quality Assurance function including staffing, budgeting, and training 2) Act as site management representative for ISO 13485 and Quality System Regulation (QSR) 3) Interface with site regulatory agencies for regulatory audits and submissions. 4) Direct the quality assurance GLP activities ensuring a high level of continued GLP compliance 5) Select, train and supervise staff to perform quality assurance functions consistent with strategic plans for ongoing implementation of the company Quality Policy 6) Determine staffing levels needed to meet these objectives and assist in formulating strategic initiatives based on trends in work levels, changes in regulatory activities and client communications 7) Develop back-ups for all activities within the quality assurance function 8) Act as management representative for the laboratory with respect to ISO 13485 and the QSR standards 9) Ensure compliance with the requirements of these and other pertinent quality standards (FDA, GMP and GLP) 10) Report to top management on the performance of the Quality Management System 11) Ensure promotion of awareness of regulatory and customer requirements throughout the organization 12) Cooperate with the Director of Operations to design and implement programs to improve overall quality and increase regulatory compliance 13) Promote individual responsibility for quality programs in each operating department through educational efforts, problem-solving support and performance feedback 14) Develop programs ensuring test validation and audits (internal, external, check sample, regulatory) and accurately assess ongoing performance to detect quality problems 15) Maintain effective corrective and preventive action monitoring program 16) Notify management of significant quality system or technical problems 17) Assist with coordination of client and regulatory audits and monitor trends in audit findings 18) Maintain personal professional competency in Quality Assurance and the biomedical industry in general 19) Operate within departmental budget 20) Recognize and understand customer’s needs and deliver in a manner that exceeds customer expectations 21) Uphold a high standard of fairness and ethics in everyday words and actions and display honesty in all business dealings 22) Communicate clearly and effectively with people inside and outside of the organization in a truthful and constructive manner 23) Demonstrate skills necessary to effectively participate in meetings 24) Work and collaborate with others toward a common goal 25) Accept change willingly and adjust to new or changed circumstances 26) Follow all company SOPs 27) Maintain confidentiality as per company confidentiality agreement 28) Develop a successor over a period of time 29) Perform other duties as directed or as necessary to meet compliance and service objectives Requirements 1) Bachelor’s degree in a scientific discipline 2) 5 years of GLP/GMP quality assurance management experience in a medical device company with 2 years of successful staff management expertise 3) Experience in budgeting and training 4) Proven track record in liaising with regulatory agencies and customers for site audits