Johnson & Johnson Careers
ASP Product Quality Specialist
Requisition ID: 1805677028W
Caring for the world, one person at the time, has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people.
Johnson & Johnson is one of the leading health care companies in the world, with over 6,000 people working for Johnson & Johnson companies in Switzerland. Johnson & Johnson’s footprint covers sites and companies across three of its sectors - Consumer Health Care, Medical Devices and Pharmaceuticals businesses, situated in a number of locations across Switzerland.
SCOPE OF THE ROLE AND BASIC PURPOSE
Provide high performance quality guidance and support for product Life Cycle Management (LCM) and enforcement of compliance with the company-wide quality management system. Provide quality support to product LCM teams, repack/relabel, CAPA, NC and IE processes.
KEY RESPONSIBILITIES / TASKS
1) Collaborate with key business partners and drive compliance and product quality issuee to completion.
2) Perform NC and CAPA investigations and support implementation of action plans
3) Support internal and external audits
4) Act as process quality subject matter expert on cross-functional project teams, as well as development and analysis of monthly and quarterly metrics
5) Communicate product and compliance risk, write, review and execute documents and procedures
6) Monitor, trend, identify issues, and collaborate with outer departments for the resolution of supplier quality issues
7) Be involved in review and approval of product change control documentation
8) Escalate issues and act as the issues escalation lead
9) Ensure that quality systems are aligned with current regulatory requirements, standards, industry trends, and J&J policies and standards
10) Support and participate in cross-functional projects when assigned/appropriate.
11) Support Supplier Quality team and Quality System Supervisor
12) Other responsibilities may be assigned and not all of those listed above may be assigned
Education / Qualifications / Training
BS Degree (science or engineering preferred) with 1-2 years of related experience and/or training in compliance, quality system and/or regulated activities in Science or Engineering Discipline
Training and demonstrated expertise on Medical Device Regulations (e.g. ISO13485, 21CFR820, etc.) and Quality Systems
Type of Experience:
2-5 years or more of experience in the Medical Device industry
Cilag GmbH International (8525)