Job Description
Support the plant manufacturing facility in assuring quality products by meeting all regulatory compliance requirements of the Quality System, performing process capability studies, determining process improvements, instituting corrective action for process & Quality System deficiencies and partnering with operations in achieving both plant Global Quality Management objectives compatible with Hollister’s Mission and Vision.
Job responsibilities:
- Serve as Quality Resource for new product development and technical services
- Lead and perform pFMEA and products/process qualifications for new product launches
- Review, evaluate and disposition non-conforming materials
- Respond to assigned CAPAs and QNs for investigation, root cause analysis and implement solutions
- Plan, coordinate, execute and document process capability, validation studies, and process improvement studies
- Create, execute and conclude results for protocols, including final reports and summaries
- Assist Sr. Quality Engineers to 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
- Assist Sr. Quality Engineers to prepare test/inspection methods including the purchase recommendation of test equipment as needed
- Conduct training on defect awareness
- Work collaboratively with Value Stream Process Engineers to identify, investigate and solve quality issues
Requirements
- 2- 5 years of experience in Quality engineering positions in medical device, pharmaceutical, biotechnological, food or related industries
- Degree in Engineering/Math/Natural Sciences/Computer Science or similar
- Knowledge and application of basic statistics and experimental design
- Ability to contribute to cross functional teams
- Very good English language skills
- Knowledge and implementation of medical device Quality System requirements (FDA and ISO)
- Experience performing internal/external audits and evaluations would be considered as an advantage
- Experience in medical device manufacturing regarding Quality System requirements per 21 CFR 820 and/or ISO 13485 preferred
- Knowledge of SAP/ERP Systems a plus
Company offers
- Professional development and career opportunities in new established manufacturing facility in Kaunas
- Extensive training in other Hollister manufacturing facilities abroad
- Opportunity to become a part of a reputable company and join their unique culture
- Attractive remuneration and benefits package
To apply for this position please send your CV in English, indicating the subject as: ”QUALITY ENGINEER in Kaunas” to: jk[eta]afr.lt or call for more details +370 645 65765.
