No relocation available-Local candidates only
The Quality Engineer will act as the liaison between Quality and Business Development OEM support, in alignment with our quality systems as it relates to changes from OEMs or affecting OEMs. The incumbent will interact with various levels internally and externally, if needed, to plan and execute changes to process or product and communicate with OEMs through business development.
- Act as a Quality Representative/Liaison between the company and business development to support OEMs.
- Manage OEM changes and communication of the changes.
- Investigate, analyze, and propose improvements and manage processes in the Quality Management System.
- Process changes through electronic document management systems including OEM changes.
- Manage reviews and approvals needed to maintain product availability during implementation of a change.
- Present data at business reviews, team meetings, management reviews.
- Bachelor’s degree in a Technical/Life Science discipline; an advanced degree is preferred.
- A minimum of four or more years in the medical device industry.
- Technical understanding of InVitro Diagnostic Assays, including Drugs of Abuse, Immunosuppressant and Therapeutic Drug monitoring Assays is a big plus.
- Understanding of GMP/QSR, ISO13485/CMDR/CE, ANVISA, JPAL and associated regulatory agencies.
- Excellent communication skills with ability to communicate at all levels within the organization.
- Ability to operate in a high paced environment.
- Able to influence, negotiate and resolve potential sticking points with diplomacy.
- Ability to lead small scale projects.
- Ability to work independently or in a group setting with little direction.
- Understanding of Design Control and Validation.
- Agile, QAD, and Master control experience is a plus.
- Position requires a 4-year degree in a Technical/Life Science area.
- Prior experience in the Medical Device industry required.
- Must be able to prepare and present technical data