The incumbent in this position is responsible, under VP level supervision, for leading, supporting and ensuring continued suitability of the Quality Management System (QMS) with a primary focus on design control, risk management, post-market surveillance, CAPA, complaints, auditing, supplier/manufacturing management, system validation, NCM/MRB, change control, document control and training. This position will also support other areas of the Quality Assurance department and additional tasks determined by management.
ESSENTIAL DUTIES & RESPONSIBILITIES
Lead the planning, design, preparation, execution, reporting, and analysis of design verification and validation efforts to approve equipment, systems, processes, and software used in the testing, processing, manufacturing, storing, and distribution of products.
Support the creation and implementation of corporate policies and procedures relating to quality, project management, process development, and FDA/ISO compliance.
Manage and maintain risk management files for multiple devices ensuring risk activities occur as required.
Coordinate and/or lead Post-Market Surveillance activities.
Oversee the Corrective / Preventive Action (CAPA), Change Control and NCM/MRB systems.
Complete evaluations, reporting, and resolution of product complaints.
Generate annual Audit Plan; manage, schedule, perform and report on internal and supplier audits. Maintain Approved Supplier List.
Lead regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design, manufacturing quality and compliance to QSR/ISO requirements.
Provide guidance to management on tools, techniques and systems for quality assurance, compliance, and continuous quality improvement.
Assist in training company employees on the principles of Quality and other QMS elements.
Provide Quality Metrics compilation and reporting.
Support Document Control and Training Record management.
Completes special projects as assigned.
EDUCATION, EXPERIENCE & SKILL REQUIREMENTS
BS/BA in science or technical field and 5 years’ Quality Assurance experience with medical devices
Strong Quality background in analysis, problem solving, process validation, risk management and statistical techniques
Project management experience
Effective time management, planning and organizational skills, with the ability to multi-task in a fast-paced environment
Broad project and process knowledge with medical devices
Previous participation in regulatory audits / FDA inspections
Experience with Document Control procedures / creation and processing of Change Orders
Excellent interpersonal and communication skills required to work effectively with all levels of staff
Ability to clearly present written information and findings at an executive level
Must be a self-starter and team player able to work with minimum supervision among all levels in the organization
Computer proficiency required in Excel, PowerPoint, Word
ESSENTIAL FUNCTIONS / PHYSICAL DEMANDS
Must be able to operate personal computer and printer
Able to work standard office equipment (photocopy machine, fax machine, etc.)
Regularly required to sit for long periods of time, with the ability to move around within the work area as needed.
Adequate vision required for computer use and reading.
Standard office environment without unpleasant or hazardous conditions. Work entails typical physical demands involved in office work with occasional off-site travel to suppliers.
Regenesis offers competitive pay, bonus plan, stock plan, health insurance benefits, matching 401k, and a generous paid time off plan.
Regenesis Biomedical is an Equal Opportunity Employer
About Regenesis Biomedical, Inc.
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.