The primary responsibility of this position is to support all aspects of the Quality Management System, with a primary focus on QA in manufacturing, incoming inspection, nonconforming materials and supplier evaluations. This position will also support other areas of the Quality Assurance department and perform additional tasks as determined by management.
ESSENTIAL DUTIES & RESPONSIBILITIES
Oversee Incoming Inspection of manufacturing and production materials
Perform Quality Assurance role on manufacturing and production floors
Manage equipment calibration, environmental monitoring and ESD programs
Support Material Review Board, participating in evaluation and disposition of nonconforming materials.
Assist in performing new supplier evaluations, monitoring existing suppliers, issuing corrective action requests and performing periodic re-evaluations
Ensure required production training is identified, completed an documented
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
Provide quality metrics compilation and reporting
KNOWLEDGE & SKILL REQUIREMENTS
Strong attention to detail
Exceptional quality background in inspection and manufacturing, with medical device manufacturing experience preferred
Able to perform minor repair work on printed circuit boards
Able to work with minimum supervision
Excellent oral and written communication skills
Intermediate computer proficiency in Excel, Word, and Outlook
EDUCATION AND EXPERIENCE REQUIRED
Associates degree or higher, with 3 - 5 years of QA experience
PHYSICAL POSITION REQUIREMENTS
Must be able to operate personal computer and printer
Able to work standard office equipment (photocopy machine, fax machine, etc.)
Ability to work on a computer up to 8 hours a day.
Regularly required to sit for long periods of time, and occasionally stand and walk.
Regularly uses hands to operate computer and other office equipment.
Close vision required for computer usage.
Occasionally required to stoop, kneel, climb and lift up to 25 pounds.
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: Company also offers a quarterly bonus plan.
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.