Senior Quality Engineer (m/w/d)

Description
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.
Location: Kiefernweg Campus, Eschweiler, NRW, Germany
Reason for open position: New role
Contract details : Permanent, Full-Time
Travel requirements: up to 20%
Start date : asap
Contact person: Katharina Steffens
Job Summary
In this role you will be the QA responsible contact to support West proprietary design and development projects. While managing the quality aspects of these projects, you will provide the corresponding teams with guidance on design quality-related issues as well as design control best practice and you will drive a culture of compliance and continuous improvement.
Your Responsibilities

• You will drive the closure of change controls and protocol deviations
• To manage activities connected to product design and development, you will review and draft procedures and forms
• Acting as the interface between development teams and operational quality, you will perform first article component and products inspections, draft defect libraries and quality inspection documents and manage formal hand over of same to Operational Quality
• In accordance with West supplier management procedures, you will support the supplier selection process
• You will be the person responsible to ensure proprietary design and development projects are executed in compliance with regulations, international standards and enterprise procedures
• In collaboration with proprietary design and development teams, you will facilitate risk assessment meetings
• You will review and approve design history file records, validation documents and metrology data
  

Your Qualifications

• To realize this role’s requirements, you have a degree in Chemistry, Engineering or Quality
• You bring 5 years of working experience in a high-volume manufacturing environment including experience in the life science industry or another highly regulated, international environment
• Desirably, you have gained knowledge of rubber and plastic manufacturing technologies as well as of analytical tools and methods – Minitab is preferred
• Project management, process technology and risk management experience according to ISO 14971 round off your profile
• While facing various projects and challenges, you are able to organize and prioritize tasks, focus on details and work in a self-motivated manner
• With your solution-orientated ability you provide excellent support to our R&D team
• You possess excellent communication skills in English, both written and verbally
  

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.