Job Description:
- Quality engineer for an operations & production site in the field of disposable medical device.
- Responsibility for QA tasks & processes within a global QA organization
- Monitor the entire production cycle and perform regular tests to identify potential malfunctions as early as possible
- Identify the root of technical issues and recommend fixes
- Change management and QMS approval processes
- Prepare reports on malfunctions and corrective actions
Requirements:
- B.Sc. or equivalent, a must.
- At least 4-5 years of experience in a quality assurance position in Medical Device or Pharma industries
- Good understanding of quality processes such as ECO, NCR, Products release, Incoming
- inspection & Training of staff.
- Experience in validations & validation reports, including production tools files and IQ/OQ/PQ - an advantage.
- Experience in Transfer to Production - an advantage.
- Excellent English with capacity to independently author quality and engineering
- documentation in English-Mandatory
- Able to prioritize workflow daily and execute on multiple priorities in a fast-paced environment
- Proficiency in Microsoft Office Suite
- Knowledge working with ERP systems such as SAP.
- Technical ability to understand, read & update specification – an advantage
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.