The QS Validation Engineer helps to ensure compliance with applicable medical device regulations through auditing, risk assessment, mitigation, validation, and data analysis with focus on management of the calibration and PM program and management of the Supplier Quality program. This position also serves as a technical resource on project teams to ensure that quality documentation exists in support of product and process changes within the quality system. Protocols may be written to qualify designs, equipment, products and processes, including software verification, to facilitate growth and change in a controlled and planned manner.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Develop validation protocols, coordinate protocol execution, and generate final reports. Includes process & equipment validation as well as software verification.
• Participate as a quality system auditor for Theragenics. Audits may also include subsidiary organizations and suppliers.
• Manage the calibration/preventive maintenance program. • Manage the Supplier Qualification program. • Develop and/or revise standard operating procedures (SOPs) and work instructions to meet applicable regulations and standards. • Assist with creation and maintenance of design history / technical file documentation. • Conduct risk assessments.
ORGANIZATIONAL RELATIONSHIPS LOCATION: Theragenics, Buford, GA DEPARTMENT: Quality Control and Regulatory Affairs REPORTS TO: Manager of Quality Systems SUPERVISES: No Direct Reports
EDUCATION: • B.S. Degree, preferably in an engineering or technical field
EXPERIENCE: • A minimum of 3 years’ experience as a medical device quality engineer.
KNOWLEDGE/SKILLS/ABILITIES: • Comprehensive knowledge of medical device quality systems regulations (ISO 13485, 21 CFR 820, ISO 14971, GMP, GDP) • Strong written and verbal communication skills • Strong interpersonal skills • Superior organizational skills with the ability to self-manage • Understanding of the importance of a calibration/Preventative Maintenance program • Independent thinker • Problem Solver • Ability to independently develop and execute validation protocols • Experience with change controls, deviation and CAPA processes • Able to use PC to generate documents and reports and to perform statistical analysis • Comprehensive knowledge of design control regulations • Knowledge of risk management regulations and processes
WORK ENVIRONMENT Some duties and responsibilities are performed in an office environment, and some are performed in a radionuclide production environment with radioactive materials. The job is typically performed under comfortable working conditions; any disagreeable elements are generally absent during normal performance of job.
CONFIDENTIALITY This position has access to or may be exposed to confidential and propriety Company information. Therefore, a high level of confidentially must be always maintained 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.