Sr. Specialist Quality Engineer

Description

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 with audits- internal, external, supplier
• Experience with customer interface and meeting customer expectations
• Excellent written and oral communication skills
• Excellent critical reading and writing skills
• Must have effective problem solving and interpersonal skills
• Ability to work independently, multi-task and thrive in fast-paced environment
• Problem solving including root cause failure analysis methods
• Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times
• English- high level in both verbal and written
  
  

Preferred Knowledge, Skills And Abilities

• Courses on topics related to quality system/regulatory requirements in the medical device industry
• Certified auditor
• Works independently and takes decisions with minimal guidance.
• Guiding other Quality Specialistsand Influence on Quality related activities across the sites
• Participates in long term or complex projects
• Uses best practices and knowledge of internal or external issues to improve Quality Management System
• Explains complex, difficult and/or sensitive information; works to build consensus
• Gaining commitments and driving for results
• Courses on topics related to quality system/regulatory requirements in the medical device
• Knowledge with ISO 13485, MDSAP, MDD 93/42/EEC and MDR 2017/745
  
  

Travel Requirements

5%: Up to 13 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Additional Requirements

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual
  
  

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening.