What are the responsibilities and job description for the Quality Systems Specialist position at RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION?
Responsible for the continuous improvement of CAPA's, Internal Audits and Quality Management System review processes. Ensures compliance with regulatory requirements, industry standards, and internal policies.
REQUIREMENTS AND RESPONSIBILITIES :
- Continuously improves and maintains the overall CAPA process, facilitates CAPA process implementation and leads CAPA review board.
- Leads CAPA investigation activities and coordinates appropriate resources to drive for root cause determinations, corrective action implementations and verification of effectiveness.
- Collaborates with cross-functional teams to support quality initiatives and continuous improvement efforts.
- Oversees effective implementation of the Quality Management System throughout the company.
- Ensures compliance of the QMS in relation to RWMIC, customer and regulatory requirements.
- Maintains the Quality Manual ensures contents are appropriate.
- Develops, implements, and monitors quality policies, procedures, and work instructions.
- Analyzes current and future procedural needs of the company.
- Organizes & manages the internal audit system and audits the corrective action reporting system.
- Conducts and leads internal QMS audits.
- Gathers data for and assists with conducting Management Review.
- Serves as a subject matter expert (SME) / mentor; supports activities in the area of Quality Management Systems.
- Designs and executes in-house training which includes QSR and ISO 13485.
- Serves as a primary interface with ISO registrar and secondary interface to outside regulatory agencies.
- Coordinates third-party audits to review divisional systems and processes as governed by CFR 820 and ISO 13485 requirements across multiple teams.
- Monitors and reports on quality data for CAPA and internal audit processes.
- Ensures risk assessment activities are executed and maintained according to regulatory standards.
ADDITIONAL RESPONSIBILITIES :
QUALIFICATIONS :
Stand / Sit / Walk 8 hours per day
Infectious Disease Exposure
At Richard Wolf Medical Instruments Corporation, we offer competitive wages and a comprehensive benefits package that includes :
We are committed to creating an inclusive workplace where diversity is celebrated. We provide equal employment opportunities to all individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, status as a protected veteran or any other legally protected status. Join us at Richard Wolf Medical Instruments Corporation and be part of our mission to advance endoscopic medicine.
