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Industry - Other Jobs
| POSITION | LOCATION | TERM |
|---|---|---|
| Corporate Quality Manager | E St. Paul, MN | Direct Hire |
| Regulatory Manager | E St. Paul, MN | Direct Hire |
#DH3484 - Corporate Quality Manager
Direct Position
Location: E St. Paul, MN Area
Salary: DOQ
This person will establish/oversee/implement incoming product (instruments
and single-use) Quality control/receiving/inspection SII/SWW.
Qualifications include:
- Bachelors degree in a technical discipline, preferably in life sciences or mechanical engineering field or equivalent combination of education and experience.
- Medical device regulatory knowledge:
- Thorough understanding of FDA Quality System, ISO 13485 and the MDD is required.
- Knowledge of other international regulations.
- 8+ years experience in a quality management environment in a medical device company.
- Experience with FDA 510(k) and TLF preparation and with incident reports/adverse events and recalls required.
- Intermediate to advance proficiency with Microsoft Office applications required.
- Demonstrated competence in both written and verbal skills required.
- Blue print reading, mechanical drafting-basic.
PLEASE CALL OR EMAIL FOR COMPLETE JOB DESCRIPTION!!!
Please send resume to shawn@daconeng.com or call 651.236.8521 (reference
#DH3484)
#SS3483 - Regulatory Manager
Direct Position
Location: E St. Paul, MN Area
Salary: DOQ
We are currently working with a medical device company that is looking for
a Regulatory Manager. This person will be managing all regulatory
activities for obtaining worldwide product approvals and preparing U.S.
regulatory submissions for 510(k)'s, IDE's, PMA's, etc.
Must have the following qualifications:
- Bachelors degree in a technical discipline, preferably in life sciences or mechanical engineering field or equivalent combination of education and experience.
- Medical device regulatory knowledge:
- Thorough understanding of FDA Quality System, ISO 13485 and the MDD is required.
- Knowledge of other international regulations.
- 8+ years experience in a regulatory management environment in a medical device company.
- Experience with FDA 510(k) and TLF preparation and with incident reports/adverse events and recalls required.
- Intermediate to advance proficiency with Microsoft Office applications required.
- Demonstrated competence in both written and verbal skills required.
- Blue print reading, mechanical drafting-basic.
PLEASE CALL OR EMAIL FOR COMPLETE JOB DESCRIPTION!!!
Please send resume to shawn@daconeng.com or call 651.236.8521 (reference
#SS3483)
Please call 651.236.8521 or e-mail us at recruiters@daconeng.com for more information on upcoming jobs in this Industry.
Please call us at 651.236.8521 if we can help you with your employment needs.
