Jobbeschreibung
Do you believe in quality, service and team spirit? Then implement these values together with us.
Make a difference as a
Senior Quality Engineer (m/f/d) Design Quality
West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2020 sales of $2.14 billion reflect the daily use of approximately 112 million of its components and devices which are designed to improve the delivery of healthcare to patients around the world.
Location: Eschweiler, North Rhine-Westphalia, DE
Department: Quality
Job summary
Reporting to the Design and Quality Assurance Director, the job holder will be the QA lead supporting West proprietary design and development projects (in elastomer and primary containment) with key focus and responsibility around the interpretation, application of and compliance to relevant standards, regulations and internal procedures. The Senior Quality Engineering Specialist will manage the quality aspects of West proprietary design and development projects, will provide West proprietary design and development teams with guidance on design quality-related issues and design control best practices, and drive a culture of compliance and continuous improvement within West proprietary design and development teams.
- Program Activities:
- Responsible for ensuring proprietary design and development projects are executed in compliance with relevant regulations, regulatory requirements, international standards, and enterprise and local procedures
- Identify and support the use of improved quality practices by R&D teams during design control activities, and facilitate the smooth integration of quality requirements into design processes
- Report on the progress of projects, identify successes, and drive compliance
- Escalate quality-related issues to the Design and Quality Assurance Director or designee, as required
- Review and approve relevant design history file documents, product drawings, component specifications, labelling, procedures
- Support design transfer activities for commercial and launch readiness and sustainment
- Verification and Validation Activities:
- Review and approve test method validations (protocols and reports)
- Review and approve design verification and design / process validation documents (e.g., protocols and technical reports)
- Facilitate and support the completion of projects up to and including PQ
- Risk Management Activities:
- Responsible for authoring and/or reviewing and approving risk management plans, risk assessments and risk management summary reports for proprietary design and development projects
- Facilitate and/or participate in risk assessment meetings with proprietary design and development teams
- QMS Activities:
- Support enterprise procedure updates that impact design and development activities
- Drive the closure of change controls and protocol non-conformance reports (PNRs)
- Review and draft relevant procedures and forms for the management of activities connected with product design and development
- Act as the interface between development teams and operational quality
- Perform first article component and product inspections
- Draft defect libraries and quality inspection documents during OQ, and manage formal handover of same to operational quality prior to PQ
- Support the supplier selection process in accordance with West supplier management procedures
- Conduct and support internal and supplier audits, as required
- Lead internal audits of R&D and support site QA in the preparation and hosting of third party and customer audits
- Lead and manage QMS activities, including CAPAs, failure investigations, non-conformance assessments, audit findings, issue reviews, document control, change controls, and configuration management; provide direction on non-conformances, deviations, or excursions and drive to closure
- Actively engage in robust problem-solving to address quality issues
- Metrology Activities:
- Review and approve metrology data during OQ and PQ
- Support quality function deployment (QFD) activities
- Compliance to all enterprise and local company policies and procedures
- Act in accordance with the company's guiding principles and adherence to the corporate code of conduct
- Compliance with all site environmental, health and safety requirements, training, and regulations
- Perform additional duties at the request of the direct supervisor
- Bachelor's degree in chemistry, engineering or quality discipline required
- 5 years working in a high-volume manufacturing environment, ideally in the medical device / pharmaceutical sectors
- Desirable: Regulatory affairs experience
- Must have practical experience working with design teams and providing design assurance support according to international regulatory requirements
- Working knowledge of ISO 13485, ISO 9001, ISO 15378 and 21 CFR Part 820 is essential
- Work experience in the life science industry or another highly regulated, international environment would be considered an advantage
- Experience in project management
- Experience in process technology, by preference with elastomers
- Risk management experience within design and development with good working knowledge of ISO 14971
- An excellent understanding of rubber and plastic manufacturing technologies, analytical methods and testing
- Knowledge of analytical tools and methods, including statistics (Minitab preferred)
- Must have critical reading skills and maintain a high attention to detail and overall quality of work.
- Must be self-motivated, able to prioritize and multitask, work independently and make sound judgements, work under time constraints, and thrive in fast-paced environments
- Strong problem-solving skills, including root cause failure analysis methods
- ISO 13485/9001/15378 Auditor or Lead Auditor training / certification upon hire is preferred
- Must have excellent written and verbal communication skills
- Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard
- Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders
- 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
- Internationality – As an American company, we live a global cooperation within international structures
- Philanthropy – We value an appreciative and friendly work environment as well as flat hierarchies
- Market-appropriate remuneration – We offer an attractive, market-oriented remuneration, including company social benefits and purchasing benefits
- Social engagement – We support local aid organizations through various actions organized by our employees
- Diversity – We at West value the wide range of our employees who make up our company
- Safety – Occupational safety is our highest priority; we offer secure jobs in a sustainable industry
- Development opportunities – Our employees benefit from an extensive range of trainings as well as from a constant and targeted employee development
- Family-friendly culture – We attach great importance to reconciling private life and work; flexible working hours are a matter of course for us