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| Job #03207 |
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| About our client |
| Our client is a global leader in processing human bone and connective tissue for relocation and an innovator in developing, manufacturing and marketing biologic, biomaterial and device systems for musculoskeletal surgery. With an exacting focus on spinal, trauma and total joint revision procedures, their current and development-stage technologies address needs within numerous musculoskeletal discipline. |
| Position |
Location |
| Quality Assurance Specialist I, II |
New Jersey |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Manage the strategic activities assigned to the QA Department by the Director of Quality Assurance (DQA) and manage/evaluate the performance of the QA staff (when required) 2) Coordinate both CA/PA and management reviews as per internal requirements 3) Assist with the development/maintenance/improvement of the quality system, in consultation with company employees and per the direction of the DQA 4) Perform external audits of potential/existing suppliers as per internal supplier qualification procedures 5) Arrange regulatory, client and notified body audits of the company facilities 6) Provide greater support to the group by taking more projects of greater complexity under limited supervision |
| Requirements |
1) Bachelor’s Degree in Engineering or BA/BS in Life Sciences or a related discipline 2) Up to 2 years of experience in RA in the medical device/pharmaceutical/life science industry 3) Understanding of ISO 13485:2003/CMDCAS standards/regulations 4) Experience in sterile, implantable products preferred 5) Excellent interpersonal, communication (written and oral) and organizational skills 6) Project management skills preferred 7) Self-motivated with a proactive attitude and ability to work independently along with an eye for detail |

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