The Regional Compliance Auditor is responsible for developing, executing and reporting on the regional audit program. This includes ensuring execution of independent annual internal audits for all regulated entities, including conformity assessment of Technical Files and Design History Files. The Regional Compliance Auditor shall also be responsible for planning and performing third party supplier audits as required to supplement site supplier approval and continuous improvement audit programs. The Regional Compliance Auditor reports to the Regional Vice President of Quality and Compliance.
Responsibilities and Duties
- Develop and execute regional internal audit schedule.
- Collaborate with Regional Quality System Auditors and Quality/Compliance VPs to develop and maintain corporate audit standards and procedures.
- Engage local site Quality teams in regional audit program, utilizing local resources to perform cross-site audits, ensuring annual independent review of each site's quality system processes.
- Compile regional audit findings for reporting to corporate management and to identify development and training opportunities based on audit finding trends.
- Perform audits, including preparation, conduct, and issuance of final audit report.
- Assist with the local site teams to develop robust corrective action plans to address compliance gaps.
- Assist in the assessment and development of auditors through training and mentorship.
- Perform periodic supplier audits on behalf of sites, to facilitate qualification or address potential issues with suppliers.
- Support Regional VP and Quality Management as necessary through assigned tasks and projects.
- Certification as a Quality Auditor from ASQ, RAPS, ISO or equivalent.
- Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits.
- Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
- Ability to travel, including valid driver's license (position entails ~50% travel).
- Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
Education & Experience
- Bachelor's Degree in Life Science, Engineering, or equivalent.
- Minimum 5 years Quality experience in medical device industry, including;
- experience as a Quality Systems Auditor,
- competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ 21CFR820 QSR, ISO17025 / ISO22301 etc)
- knowledge of relevant laws and regulations (e.g. CE/ FDA/ PAL)
- and competency in conducting technical review of all documentation and files related to product conformity requirements.
- Broad knowledge of engineering and technical applications applied in development of medical devices useful.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales