Quality Auditor - Supplier Auditor

Description

Perform all work in compliance with company policy and within the guidelines of BioMerieux's

Quality System.

2.Establish supplier audit schedules and activities.

3.Perform gap analysis of supplier QMS to new and existing regulations and standards.

4.Present supplier audit findings at annual Management Review meeting.

5.Present supplier audit findings and OFI's to Supplier Program Manager, and members of Supplier Review

Board/Material Review Board.

6.Understand company organization, operations, product development cycle and management processes.

7.Understand QMS organization and QA functions.

8.Maintain supplier audit finding database (SCARs).

9.Evaluate supplier audit findings and opportunities for improvement.

10. Review supplier audit findings and opportunities for improvement for trends over time.

Supplemental Data

1.5-10% Domestic and/or international travel may be required for training purposes.

2.10-20% domestic and/or international travel may be required for performing supplier audits

Note: Travel may be restricted during times of high risk to travelers. Supplier audits may be performed remotely

as deemed necessary by management

• Bachelor of Science or Master's Degree (science, engineering or life sciences).

2.Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and 21 CFR 820 required.

3.Knowledge of quality principles and regulations applicable to in vitro diagnostic products, including FDA

QSR, ISO 13485, CMDR, CE Marking, ISO 9001, ISO 14971, In Vitro Diagnostic Directive/In Vitro Diagnostic

Regulation.

4.Knowledge of MDSAP audit program a plus.

Experience

1.Minimum 5 years work experience in Medical Device, Pharmaceutical or Biotechnology manufacturing

setting that has a formal quality system is required.

2.Auditing experience in Medical Device, Pharma, or Biotechnology industry.

Knowledge, Skills, and Abilities

1.Effective written and verbal communication skills

2.Proficiency in MS Office tools, including Outlook, Word, and Excel

3.General computer operation

4.Proficiency in internet navigation

5.Attention to detail is fundamental to this position

6.Strong organization is required

7.Auditing principles and best practices

8.Ability to accurately follow and interpret written procedures

9.Ability to accurately comprehend and interpret federal and international regulations and standards.

10. Excellent communication skills, both oral and written

11. Excellent collaboration with cross-departmental leaders within the organization.

12. Professional communication and peer-to-peer interactions is a must.

13. Critical listening skills

14. Experience with MS Visio a plus

15. Ability to prepare clear and concise summaries for executives and stakeholders.

16. Strong presentation skills.