Vacancy expired!
- 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
Vacancy expired!