Job Description
- Respond to assigned customer complaints and CAPAs for investigation, root cause analysis and implement solutions.
- Plan, coordinate, execute and document studies for process capability, validation and process improvement.
- Create, execute and conclude results for protocols including final report and summaries.
- Perform Gage R&R studies and DOEs as needed.
- Support Operations and GQM strategic plans in leading or supporting projects.
- Lead and facilitate internal audits and assist in performing vendor audits.
- Plan, coordinate, and document Quality Plans and work instructions.
- Prepare test/inspection methods including the purchase recommendation of test equipment as needed.
- Conduct training on defect awareness, statistical techniques and regulatory requirements.
- Work collaboratively with Value Stream Process Engineers to identify, investigate and solve quality issues.
Requirements
- Ability to live abroad at the initial stage (up to 1 year)
- Knowledge and implementation of medical device Quality System requirements (FDA and ISO)
- Experience in microbiology and sterilization (gamma/EtO), working with clean rooms
- Knowledge of SAP/ERP Systems preferred.
- Very good English language skills.
Company offers
- Professional development and career opportunities in new established manufacturing facility in Kaunas
- Extensive training in other Hollister manufacturing facility abroad
- Opportunity to become a part of a reputable company and join their unique culture
- Attractive remuneration package
