Provide guidance and ensure compliance with the Quality System Regulations including FDA, ISO 13485, and applicable international regulations. Develops and implements strategies for implementing the company’s quality objectives through the activities of the department and cross-functional quality teams. Serves as a mentor to company personnel by training in quality system requirements and the use of quality tools for continuous process improvement. Provides guidance to internal departments on quality and compliance issues.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- 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
- Manages the CAPA System and runs the CAPA Review Board.
- Manages the Non-Conformance System.
- Helps maintain technical documentation.
- Directs the activities of all Quality 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.
LOCATION: CP Medical
DEPARTMENT: Quality Control & Regulatory Affairs
REPORTS TO: VP of Operations
SUPERVISES: Quality System Supervisor
- B.S. Degree, in a related science or technical field or post high school with equivalent work experience.
- 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.
- 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.
The job is typically performed under comfortable working conditionsin an office, warehouse or clean room environment where light manufacturing is performed; any disagreeable elements are generally absent during normal performance of job.
This position has access to or may be exposed to confidential and propriety Company information. Therefore, a high level of confidentially must be maintained at all times with any Company information.
LIMITATIONS AND DISCLAIMER
The above position description is meant to describe the general nature and level of work being performed; the position description is not a comprehensive or exhaustive list of all duties, responsibilities of skills required for the position. Management has the right to assign or reassign duties and responsibilities to or from this position at any time.
To perform this position successfully, the employee must be able to satisfactorily perform each essential position duty and responsibility. All position requirements are subject to possible modification to reasonably accommodate individuals with disabilities
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