The primary responsibility of this position is to support all aspects of the Quality Management System, with a primary focus on Quality Assurance in change management, document/records control, training, and complaint handling. This position will also support other areas of the Quality Assurance department and additional tasks determined by management.
ESSENTIAL DUTIES & RESPONSIBILITIES
Assure all Operations, Marketing, Manufacturing and other documents have accurate / complete content, references, etc. and fully satisfy internal and agency compliance expectations
Coordinate/document Change Control Board activities
Oversee Employee Training; verify training effectiveness is completed
Manage Quality Records inventory; perform annual records audit; archive/retrieve records as necessary
Organize periodic documentation reviews
Support complaint handling responsibilities
Assist in the completion of corrective/preventive actions (CAPAs)
Support implementation of corporate policies and procedures related to Quality Assurance and FDA QSR/ISO 13485 compliance
Must be PC literate with advanced MS Office skills (Word, Excel, PowerPoint, Visio, Outlook)
Proficient in editing PDF documents
Interpersonal and communications skills to work effectively with all levels of staff
Strong attention to detail
Flexibility and creativity
Excellent organizational skills
Strong time management skills and multi-tasking abilities
Ability to manage projects, alone or as part of a team
Able to work with minimum supervision
Good oral and written communication skills
EDUCATION, EXPERIENCE & TRAINING REQUIRED
Two years of college or equivalent experience
1-3 years Quality Assurance experience
AutoCAD, KeyCAD or CAD Lite experience
Knowledge of FDA Quality System Regulation and ISO 13485 requirements
Familiarity with CMS requirements
Scientific Literature searches
Associates or BA/BS in related field
Regenesis offers competitive pay, bonus plan, health insurance benefits, matching 401k and a generous paid time off plan.
Regenesis Biomedical is an Equal Opportunity Employer
Additional Salary Information: Salary is dependent upon experience.
About Regenesis Biomedical
Regenesis Biomedical is an Arizona based medical device company dedicated to improving human welfare through the research, design, manufacture, and sale of energy-based medical products and services that alleviate pain, restore health, and improve quality of life. As a company, we value dedication, innovation, integrity, respect, excellence, compassion and teamwork.