Manager Quality Systems (Medical Device)
Our client in Norcross, Ga has an immediate opening for a Manager Quality Systems. The primary role of the Manager Quality Systems is to provide guidance and ensure compliance with FDA’s Quality System Regulations and ISO 13485 standard, and other applicable international regulations. This will also include developing and implementing strategies for the company's quality objectives through the activities of the department and cross-functional quality teams. This role will serve as a mentor to company personnel by training in quality system requirements and the use of quality tools for continuous process improvement.
- Manage the implementation of the company’s quality objectives through specific improvement projects and routine processes.
- Serve as mentor to other departmental personnel by training in QSRs and the use of
- Quality tools for continuous improvement.
- Provides guidance to other departments on quality and compliance issues.
- Actively participates in CAPA’s investigations and corrective actions.
- Manages the Non-Conformance System.
- Helps maintain technical documentation.
- Directs the activities of all QC department employees.
- Trains and instructs employees company-wide in quality system requirements and company procedures.
- Reviews and comments on the work of others to ensure compliance with quality system requirements.
- Participate in Risk Management activities such as; reviewing and approving risk documents when appropriate; participating in risk management review meetings; Providing or ensuring that information necessary for risk management activities is provided/obtained; reviewing and mitigating new risks based on the data reviewed.
- B.S. Degree, in a related science or technical field.
- Minimum 5 years’ experience working in quality systems, or GMP/ISO regulated industry, with experience in a supervisory role.
- Experience in medical device industry required.
- Minimum three years’ experience in managing technical and professional personnel.
- Written and verbal skills must be excellent. Must be able to create clear, concise communications to regulators.
- Must have project management skills with the ability to lead and participate in cross-functional new product teams.
- Excellent interpersonal skills that foster cooperation and commitment.
- Detail-oriented with a sense of urgency for completing projects on schedule.
- Ability to deal effectively with a variety of internal and external operational and scientific personnel with varying degrees of education and experience.
- Must be able to prioritize multiple duties and projects.
- Must be familiar with computers and able to word process documents and compile and organize data. (MS Office and other Windows based software)
- Must possess strong knowledge of design controls.
- Ability to delegate laterally to complete activities and projects.
- Knowledge of process, product and software validations is strongly preferred.
- Understanding of QSR/ISO regulations, product quality, PFMEA, and product testing methods
- Strong knowledge of statistics, process control, and process capability techniques.
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