Sr. Specialist, Quality System Eng

Description

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

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 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, maintain the quality system procedures by verifying their compliance to relevant regulatory requirements, lead quality related matter regarding MDR and other regulatory requirements.
• 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, as well as ensure nonconformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s
• Lead and perform risk-based approach (risk assessments) processes and implement control plans.
• 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.).
• Responsible for the QA approval of employees’ training files and approval of employees’ qualification certificates.
• 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, and for presenting the data during Management Reviews
• Responsible for the site’s procedures alignment with applicable West Enterprise procedures.
• Interact and collaborate with Laboratory; Operations, Engineering, R&D, RA, D&T and other functions to support resolution of Quality issues and investigations.
• Maintaining the quality system procedures by verifying their compliance to relevant regulatory requirements.
• Lead the activities to Identify and verify quality agreements with Economic Operators are up to date with the state of the art EU/US and ROW regulatory requirements along with references to the applicable SKU and distribution zones to the relevant customer/EO
  
  

Basic Qualifications

• B.Sc./ BA in Science. Chemistry/ Biology/ Eng. – an advantage
• Minimum 5 years working in quality system/regulatory in the Medical Device/Pharma industry
• Experience with ISO 13485, ISO 14971, MDSAP, MDD and EU MDR regulations - advantage
• 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
  
  

Preferred Skills

Preferred Knowledge, languages , Skills and Abilities:

• Courses on topics related to quality system/regulatory requirements in the medical device industry
• English- high level in both verbal and written
• Certified auditor
• Works independently and takes decisions with minimal guidance.
• Guiding other Quality Specialists
• 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
• English- high level in both verbal and written
  
  

(already in #3) Travel Requirements:

audits (about 5% )

Competencies/Authorities

• Contract review approval
• Write, review and approve Quality documentation
• Auditor
• CAPA approval
• Effectively communicate and interface with various levels internally
• Observe and interpret situations, analyze and provide guidance in different teams’ problems solving
• Leading root cause analysis projects
• Leading improvement projects, using six sigma/lean tools
  
  

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 [email protected] . 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.