Senior Quality and Regulatory Systems Auditor
Industry Title
/Category: Medical Device/ Regulatory
Job ID: 2011-5004
Career Level: experienced
Location/Division: Murray Hill, NJ/ Corporate
Relocation: Yes
Posted Date: 5/13/2011
Close Date: ..
C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.
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Summary of Position with General Responsibilities:
The Senior Quality and Regulatory Systems Auditor is responsible for implementing quality and regulatory audits of C.R. Bard and supplier facilities and products and for providing training and guidance for corporate and internal auditors. In this role, he/she assists the Director, Corporate Regulatory and Quality Audit with the planning of required annual audits and other audits as needed and assigned. He/she conducts in depth audits of quality and regulatory activities for compliance with applicable regulatory standards and functions as a subject matter expert for quality and regulatory issues. He/she provides leadership to the corporate audit team and Divisional/site internal auditors as needed in the conduct of audits, documentation of findings, support for auditee development of audit action plans and evaluation of effectiveness checks. He/she assures high quality reporting of audit findings and interfaces with division and manufacturing facility management to promote effective auditee corrective action plans.
Essential Job Functions:
1. Provides leadership to the corporate audit team for the implementation of regulatory, quality (including design control) and quality system effectiveness audits of divisions, plants and suppliers by functioning as audit team leader.
2. Conducts routine and directed audits as assigned to assure compliance with FDA regulations, international standards and requirements, local SOP’s and corporate standards.
3. Provides guidance and coaching for corporate auditors in the conduct of audits, documentation of findings, support for auditee development of audit action plans and evaluation of effectiveness checks.
4. Acts as a subject matter expert for quality and regulatory audits and, as such, maintains a comprehensive knowledge of FDA quality and regulatory requirements and their interpretation, along with knowledge of international standards and requirements.
5. Provides guidance and direction to division and manufacturing facilities in the development of corrective action plans including corrections, corrective actions, preventive actions and effectiveness checks to address corporate audit findings.
6. Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate.
7. Assists his/her management in optimizing resource utilization in the development of audit plans and implementation of audit schedules.
8. Provides support to management in the development of formal auditor training programs for corporate, division and plant internal auditors.
9. Provides auditor training to corporate audit staff, internal auditors and supporting auditors as assigned through formal classroom training, web based or on-the-job training.
10. Supports his/her manager in the development of quarterly and annual audit metrics and summaries for distribution to key division and manufacturing management.
11. Support management development of Corporate Policies, Standards procedures and guidelines as assigned to support the corporate audit program.
12. Maintains corporate audit files to assure conformance with applicable regulatory requirements.
Basic Qualifications:
B.S. degree in Engineering or the Physical or Biological Sciences
6+ years auditing of quality and regulatory systems for medical device manufacturers
Knowledge of FDA quality systems regulations for medical devices
Effective verbal and written communications at all levels of management
Additional Desirable Qualifications Skills and Knowledge:
Knowledge of FDA regulatory requirements for pharmaceuticals and combination products
Certified Quality Auditor/ISO lead Auditor Certified
M.S. or PhD in Engineering or the Physical or Biological Sciences
Experience/working knowledge of design controls and regulatory systems as applied to medical devices
Strong analytical skills and a high standard of judgment to identify significant quality and compliance issues
Physical Demands:
Incumbent must be physically able to travel domestically and internationally
(Travel is 40% - 60%)
