Quality Systems Specialist - Millenniumsoft : Job Details

Position : Quality Systems Specialist

Location : Research Triangle Park, NC

Duration : 12 Months Contract

Total Hours/week : 40.00

Shift Timings : 8 AM – 5 PM

General Function:

This position will function within the Quality Assurance Unit of Corporate Preclinical Development and Toxicology (CPDT) and will participate in the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with FDA GLP regulations and the client CPDT Quality System.

The Quality Systems Specialist is accountable for support of the continued development, improvement and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions and problem solving techniques to promote New Product Development and provide support to project teams for process improvement and continuous improvement activities.

Primary Responsibilities and Duties:

• Responsible for performing audits of data and reports, phase auditing and internal auditing in direct support of 21 CFR Part 58 and the overall Quality System. Quality Assurance Unit documentation/activity support applies to most aspects of the systems employed by client CPDT for material risk assessments, material characterization, and internal/external GLP biocompatibility testing for medical devices as described in ISO 10993 and FDA G95-1.
• Operate the client CPDT Document Control system for all controlled documents including but not limited to forms, Policies, Protocols, Reports and Standard Operating Procedures.
• Support the client CPDT Training System to ensure training is performed and documented in order to maintain compliance to Quality System and regulatory requirements.
• Active Participation in the development, implementation and maintenance of various aspects of the client CPDT Quality System including creating and reviewing documents (SOPs, Procedures, Methods, Protocols) in overall support of continual quality improvement.
• Adhere to the requirements of the Metrology program including maintenance of Regulatory Asset Manager System.
• Maintain an environment of continuous improvement and quality aligned with client core values and strategic objectives.

Position Requirements:

Education/Experience:

• Typically requires a minimum of a Bachelor's Degree in a scientific discipline.
• A minimum of 2 years relevant experience or a combination of equivalent education and relevant experience.

Knowledge:

• Moderate level of application of Quality System Standards to assigned Quality system area.
• Working Knowledge of Quality Systems Regulatory requirements and application to Company/Unit requirements

Skills:

• Demonstrated ability to work successfully independently as well as part of a team.
• Excellent verbal and written communication skills.
• Must have the ability to focus and to execute multiple projects and programs simultaneously while maintaining attention to detail.
• This position requires excellent organizational and the ability to adapt rapidly to changing priorities in a high volume scientific testing laboratory.