Engineering Management & Business Others Medical and Healthcare Other Science and Tech
3 - 5 Years
Sr. Quality Engineer
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Primary objective of position
Support quality system activities within the AVN quality system (QMS) in compliance with the AV QMS, international standards and regulatory requirements.
Support the maintenance of the AVN quality system including implementation of QA objectives.
Give guidance advice and mentorship to the AVN organization on quality related subjects/processes.
Overall coordination and follow-up on exceptions
Support process owners with implementation of quality requirements for processes within the AVN QMS.
Provide Quality Assurance advice to process owners within the scope of the AVN QMS.
Act as a delegate in one or more QMS processes.
Develop and provide training on applicable quality related subjects.
Play a key role in external and internal audits performed at AVN
Support supplier audits.
Analyze data to identify trends and opportunities for improvement on quality aspects.
Support validation activities.
Lead AVN Q improvement projects & support AVN projects (e.g. integrations).
Use and establish analysis techniques and other quality control tools to aid decision making.
Identify opportunities for quality system and quality process improvements and work with task teams in achieving these.
Product Build Method review relating to addendum labeling and rework
Education & Knowledge
Bachelor of Science in Engineering (or equivalent)
Min. 3 years of relevant working experience in a highly regulated environment (preferably in medical technology/logistical operational environment)
Min. 5 years of relevant working experience in a highly regulated environment (preferably in medical technology)
Experience in Senior Role (E.g. Senior, supervisor, manager)
Experience in implementation of Quality Systems
Experience of supplier quality engineering including supplier selection, supplier auditing, supplier monitoring and issue resolution.
Experience supervising one or more employees
Experience and certification of ISO13485 auditing (knowledge of 21 CFR 820).
Experience of working in medical device or Pharmaceutical packaging and labeling areas and understand best practices in terms of process controls in these areas.
WHAT DO WE OFFER?
Abbott provides a varied, challenging position in a dynamic and pleasant working environment. In our organization, you can count on excellent primary and secondary benefits (for example: holiday payment, 13th month salary, pension) a positive working atmosphere, a personal growth plan, extensive training opportunities and good career perspective.
HOW TO APPLY?
If you are interested in this vacancy, in working at Abbott, and you recognize yourself in the aforementioned description, then we are interested in receiving your cv. You can apply by sending in your cv and motivation via our website. For more information you can contact Valeria Calenici, Recruiter via email@example.com.
Part of our selection process is checking references and we will require your Certificate for Conduct. An assessment center can also be part of the recruitment process.