Title:  Senior Specialist Quality Systems Engineer

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

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:

1. The Sr. Specialist, Quality System Engineer will be a Quality advocate across the West IL sites and across the West IL Contract Manufacturing sites (3 CM sites)
2. The Sr. Specialist, Quality System Engineer will have an in-depth knowledge and experience of the applicable regulatory requirements and will make sure those are implemented throughout the quality management system.
3. Act as one of the site’s Lead Internal Auditor
4. Responsible for the site’s internal audit program- managing the internal audit plan as per applicable regulatory requirements, lead audits, collaborate with additional auditors, maintain the pool of auditors, review and approve audit reports, set corrective actions and perform follow ups.
5. Lead and perform risk-based approach (risk assessments) processes and implement control plans.
6. Responsible to ensure nonconformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s
7. Responsible for site improvement projects related to Quality processes – such as (but not limited to- Data integrity, Lean/Six Sigma projects, CoPQ/cost reduction, etc.).
8. Responsible for the QA approval of employees’ training files and approval of employees’ qualification certificates.
9. Responsible for the sites’ metrics and KPI data collection and analysis, including weekly, monthly (including MBR) and routine reports, both internally and externally. Collaborate with both internal and external stakeholders in relation to metric reporting. Identify trends in applicable areas, analyze, evaluate and initiate applicable actions to mitigate.
10. Responsible for the site’s procedures alignment with applicable West Enterprise procedures.
11. Interact and collaborate with Laboratory; Operations, Engineering, R&D, RA, D&T and other functions to support resolution of Quality issues and investigations.
12. Maintaining the quality system procedures by verifying their compliance to relevant regulatory requirements.
13. Responsible for preparations of periodical management reviews, including data analysis, supporting data evaluation for other departments.
14. Support other QA/MQ dept activities- graphics and batch release, audits, CAPA/ Corrections review and approval, customer complaints, external audits, etc.

Basic Qualifications: 

1. B.Sc./ BA in Science. Chemistry/ Biology/ Eng. – an advantage
2. Minimum 5 years working in quality system/regulatory in the Medical Device/Pharma industry
3. Proven experience with ISO 13485, ISO 14971, MDSAP, MDD and EU MDR regulations   
4. Experience with audits- internal, external, supplier
5. Experience with customer interface and meeting customer expectations
6. Excellent written and oral communication skills
7. Excellent critical reading and writing skills
8. Must have effective problem solving and interpersonal skills
9. Ability to work independently, multi-task and thrive in fast-paced environment
10. Problem solving including root cause failure analysis methods
11. Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
12. Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
13. Able to comply with the company’s safety policy at all times

Preferred Knowledge, languages, Skills and Abilities:

1. Courses on topics related to quality system/regulatory requirements in the medical device industry
2. English- high level in both verbal and written
3. Certified auditor
4. Works independently and takes decisions with minimal guidance.
5. Guiding other Quality Specialists
6. Influence on Quality related activities across the sites
7. Participates in long term or complex projects
8. Uses best practices and knowledge of internal or external issues to improve Quality Management System
9. Explains complex, difficult and/or sensitive information; works to build consensus
10. Gaining commitments and driving for results
11. Courses on topics related to quality system/regulatory requirements in the medical device 
12. Knowledge with ISO 13485, MDSAP, MDD 93/42/EEC and MDR 2017/745
13. English- high level in both verbal and written
14. Certified auditor

Travel Requirements:

1. Must be able to travel up to ____5___ % of the time (audits)

Physical & Mental Requirements:

1. Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body.  Sedentary work involves sitting most of the time.  Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met
2. Effectively communicate and interface with various levels internally
3. Observe and interpret situations, analyze and provide guidance in different teams’ problems solving

Delegation/s (Title):

Manager, Quality System Engineering/ qualified Quality personnel

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.