Quality Systems Specialist

at Richard Wolf Medical Instruments Corporation in Vernon Hills, Illinois, United States

Job Description

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:
Complies with regulatory requirements using Good Documentation Practices (GDP).
Aware of and complies with the RWMIC Quality Manual and regulations & requirements as they apply to this job type/position.
Completes all planned Quality & Compliance training within the defined deadlines.
Other duties as assigned by Regulatory Affairs Manager or US Head of Regulatory Affairs - QA/QC.
QUALIFICATIONS:
Bachelor's degree in a relevant field such as Engineering, Quality Management, Life Sciences, or a related discipline preferred.
Minimum of 3-5 years of experience in quality systems, preferably in a regulated industry (e.g., medical devices, pharmaceuticals, manufacturing).
Working knowledge of 21 CFR 820 and ISO 13485
Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams at all levels.
Excellent time management skills, ability to prioritize workloads, and organizational skills.
Strong attention to detail and accuracy
Intermediate PC skills and familiarity with all MS Office suite products
Applied understanding of statistical methods and spreadsheets
Working knowledge of SAP
Experience with and understanding of cross-cultural differences and the ability to work within this environment is crucial for successful employment.
The following physical demands are required:
Stand/Sit/Walk 8 hours per day
The following work environment conditions may exist:
Infectious Disease Exposure
Chemicals Exposure
RWMIC offers annual Immunizations for Hep B and Flu Shots to all RWMIC employees. RWMIC employees have the responsibility to themselves and the company to consider receiving these immunizations.
All RWMIC Employees have the responsibility to themselves and the company to work safely.

At Richard Wolf Medical Instruments Corporation, we offer competitive wages and a comprehensive benefits package that includes:
401(k) Retirement Savings Plan with Matching Program
Medical Insurance, Dental, and Vision Insurance
Paid Holidays, Vacation, Sick/Personal Days
Flexible Work Hours (Flex Time)
Tuition Reimbursement
Life Insurance and Disability Insurance
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.

At Richard Wolf Medical Instruments Corporation (“RWMIC”), we are committed to maintaining an environment of Equal Opportunity and Affirmative Action.