Quality System Engineer
Job ID :
US - New York - Rochester
- Champion the implementation of QMS tools and technologies to enhance compliance to current standards, regulations and Corporate requirements.
- Contribute to and execute a strategy for the implementation of QMS initiatives
- Drive initiatives to improve usability of QMS procedures and instructions
- Facilitate improvements of the QMS and provide training in QMS and Good Manufacturing Practices (GMP)
- Manage and improve the CAPA process acting as the site’s CAPA coordinator
- Manage the Internal Audit process.
- Host and follow up on notified body audits
- Project manager/representative on implementation of new eQMS activities
- Manage current paper and eQMS systems
- Create and coordinate creation of key procedures and processes based on feedback, set quality goals and to ensure customer agreement fulfillment
- Support internal functional partners and ensure that all aspects of the QMS are understood, implemented and maintained.
- Work closely with all personnel to ensure that aspects of the QMS are understood, implemented and maintained.
- Bachelor’s degree in science or technology field or equivalent three to five year experience
- Working experience with ISO 13485 and with medical device regulations (i.e. MDD 93/42/EEC, FDA 21 CFR Part 820)
- Well organized and structured
- Posses strong analytic and problem solving skills
- Excellent ability to write documents and describe processes and procedures
- Experience in auditing techniques as well as interpreting and transforming requirements to practical implementation
- Attention to detail with good understanding of the big picture.