Job Function Summary:
Responsible for providing leadership, managing, planning, executing and reporting on regulated Quality Assurance activities for internal/external audits. This individual is responsible for performing Internal, domestic and international audits(as appropriate) that ensure compliance with the FDA QSR , ISO, MDD, CMDR requirements, and other worldwide health authority regulations/guidelines, site SOPs, protocols, and industry standards, as applicable. The Auditor acts as a compliance resource and provides recommendations for corrective action and tracks corrective action commitments until closure.
- Independently plans, conducts, and documents internal and external audits to assess compliance with the applicable standards and regulations and company SOPs.
- Plans, executes and prepares clear and concise written reports of audit or review observations, including an assessment of compliance during internal audits of facility quality systems.
- Supports Quality management, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time, and that audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule.
- Facilitates and consults with corrective action teams in implementing changes to ensure compliance with all applicable QSR/ISO//MDD/CMDR and other applicable requirements.
- Performs re-audits and/or effectiveness verifications as a way of assessing and documenting CAPA Effectiveness
- Issues to management timely written audit reports and follows up on audit activities to ensure appropriate corrective action.
- Escalates audit findings to the appropriate level of management.
- Assists during third party audits.
- This is not an inclusive list of job responsibilities.
Required Skills and Abilities:
- ISO 13485 Lead Auditor for one year is required.
- Minimum of three years Quality Auditing experience conducting and participating in the Medical Device industry is required.
- ASQ -CQA (Certified Quality Auditor) is preferred.
- Ability to prioritize and multi-task successfully in a fast paced environment
- Ability to work both independently and in a collaborative team setting.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
Getinge is an EO employer – M/F/Veteran/Disability