Medical Device Quality Engineer
5 - 7 years experience • IT Consulting/Services
We are looking for Medical Device Quality Engineer for our client in Cincinnati, OH
Job Title: Medical Device Quality Engineer
Job Location: Cincinnati, OH
Job Type: Contract – 12 Months / Contract to Hire / Direct Hire?
“US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time.”
Contract Quality Engineer, Integration
- This position will assist with the quality system integration of a newly acquired medical device company with the new parent company.
- This person will provide leadership and project management skills to plan, organize, and execute activities required to ensure the newly acquired company meets the quality system requirements of both federal and regulatory standards, as well as corporate procedures
- This person will help to harmonize the quality system procedures, processes, and systems between the acquired company and the parent company.
- This person will collaborate with cross-functional teams to support the overall integration effort.
- This person will communicate progress of quality integration efforts and quality system compliance risks.
- Perform gap assessments between the two quality systems and ensure timely corrective and preventive actions to address any remediation efforts that are required as the result of gaps found.
- Support internal and external audits
- Other responsibilities may be assigned and not all responsibilities listed may be assigned.
- A BS Degree in technical science or engineering or BA in business, quality is required.
- A minimum of 4years of related experience is required, preferably in a regulated industry
- Personal computer skills, Windows: word processing, project planning, presentation, e-mail and spreadsheet software
- Experience in audits (either as auditor or auditee) to ISO standards for QMS, MDD, FDA QSR and CMDR, required.
- Experience with quality systems is required.
- General knowledge of medical devices regulatory requirements is necessary. Experience in the medical devices or pharmaceutical industry is preferred. Possess a demonstrated track record of achieving successful compliance.
- Proven success in: Accountability, with a strong desire to commit, and be held accountable for delivering results.
- Must have strong collaboration skills to partner effectively with Operating Company functions and across Operating Units. Proven track record of demonstrating collaboration across organizations at multiple levels
- Strong analytical skills and experience
- Change management and project management experience
- Communication – demonstrate the ability to discuss complex quality issues and concepts in a clear and concise manner, orally and in writing - with all levels of management
- Detail oriented
- Ability to travel25% of the time, required.