Position #1524: Quality Assurance Validation Engineer
- Posted: 08/31/2017
- Closes: When Position Filled
- Our client is the market leader in providing high quality resorbable polymers in the field of medical devices and pharmaceutical applications. These resorbable polymers are used in orthopedic implants, drug delivery systems and surgical suture applications among others.
Our client is looking for a Quality Assurance Validation Engineer who will be responsible for but not limited to, working with the team in developing and implementing product, process, equipment, and validation protocols, as applicable to ensure compliance to applicable regulatory requirements, internal company standards and industry practices. You will be executing IQ/OQ/PQ protocols and making recommendations for changes and/or improvements. As the new QA Validation Engineer, you will report to the Director, Quality and Regulatory Affairs.
• Develop, write and execute validation protocols (IQ/OQ/PPQ, etc.), for equipment, systems, products and processes, write master validation plan and final validation reports.
• Assist in establishing user requirement specifications (URS) and manage them in the quality system.
• Work in self-directed manner and must be able to work on SOPs, Component Specifications and other documentation as required.
• Ability to work effectively under time constraints and cope with technical adversity within a team environment. A minimum of a BS degree in Engineering or Science or similar field is required.
DO NOT APPLY FOR THIS POSITION UNLESS YOU MEET THESE MINIMUM QUALIFICATIONS:
• BS Degree in Engineering or Science.
• Minimum of 4-7 years of experience in product development, manufacturing and/or quality with medical device companies.
• Thorough working knowledge of Medical Devices Quality System Regulations (21 CFR 820), ISO 13485 and other applicable regulations.
• Self-starter with excellent technical writing, analytical and interpersonal skills to allow effective participation in project teams.
• Working knowledge of medical device manufacturing system requirements - 21 CFR 820, required, knowledge and understanding of document control/change control practices, FDA Regulations and ISO Standards, Design Control System, and automated document control/change control systems.
• Experience in general quality assurance methods and practices in equipment/ process/ product validation, quality improvement, quality management systems, corrective and preventive action, root cause analysis.
• Strong understanding of statistical concepts.
• Good communication and writing skills and be able to work effectively with all levels of individuals within the organization.
• Experience in working with regulatory agencies, including FDA audits and filings.
• Knowledge of FDA 21 CFR 820, 21 CFR 210/211, ICH Q7, ISO 13485, cGMPs.
• EU Medical Device Directive and relevant elements of quality management requirements preferred.
• Proficient in standard Microsoft software, i.e. Outlook, Word, Excel, PowerPoint, and displays strong performance in Project
- Location: Atlanta, GA
- Compensation: $80,000 - $100,000
- Benefits: 10% Bonus
Qualified candidates please reference Position #1524
when submitting your resume to Search
or mail to: The Lake City Group.
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