Sr. Specialist Quality Engineer

This role is a hybrid position, 3 days in office/2 days remote with some travel 1x in 3 months to Shlomi   At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?     There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.     We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.   Job Summary

This hybrid role for the Senior Specialist, Quality System Engineer will ensure the West IL Quality Management System consistently meets the regulatory, enterprise and customers’ requirements. The Senior Specialist, Quality System Engineer will be responsible for developing and implementing continuous monitoring and improvement of the Quality Management System according to applicable regulatory requirements- MDD 93/42/EEC, Medical Device Regulation (MDR) 2017/745, 21 CFR 820, MDSAP, ISO 14971, ISO 13485 etc. and will make sure the QMS is maintained and effective . Senior Specialist, Quality System Engineer will provide support with the analysis of quality issues to identify root causes and implement corrective action to reduce risk of quality failures. Essential Duties and Responsibilities

The  Sr. Specialist, Quality System Engineer  serves as a Quality advocate across West IL sites and West IL Contract Manufacturing sites, ensuring compliance with applicable regulatory requirements and implementation within the Quality Management System. Acts as a site Lead Internal Auditor and manages the internal audit program, including audit planning, leading audits, maintaining the auditor pool, reviewing and approving audit reports, defining corrective actions, and ensuring follow-up. Leads risk-based quality processes, including risk assessments and control plans. Ensures nonconformances, deviations, and complaints are investigated, root causes are identified, and effective CAPAs are implemented and closed. Drives quality improvement initiatives such as data integrity, Lean/Six Sigma projects, cost reduction, and continuous improvement activities. Approves employee training files and qualification certificates. Collects, analyzes, and reports site metrics and KPIs, including weekly, monthly, MBR, and routine reports. Identifies trends, evaluates risks, and initiates mitigation actions as needed. Ensures site procedures are aligned with West Enterprise procedures and regulatory requirements. Supports quality issue resolution with relevant functions such as Laboratory, Operations, Engineering, R&D, RA, and D&T. Supports management reviews, batch release, graphics review, audits, CAPA/correction review and approval, customer complaints, and external audits. Responsible for customer Quality Agreements, including initiation, coordination, follow-up, and ongoing maintenance. Additional Responsibilities

Ensure adherence to corporate Quality System requirements Education

B.Sc. in Sciences/Engineering or related required Work Experience

Minimum 5 years working in quality system/regulatory in the Medical Device/Pharma industry highly preferred Proven experience with ISO 13485, ISO 14971, MDSAP, MDD and EU MDR regulations    Experience