Senior Corporate QS Compliance Auditor, Murray Hill, New Jersey

Scope of the Job:

The QS Compliance auditor shall have responsibility for the establishment and execution of the Corporate Quality Systems Compliance audit program. The QS Compliance auditor is responsible for the assurance of compliance to applicable Regulatory standards.

Department: Corporate Quality Systems

Reports To: Staff Vice President of Quality Assurance

Responsibilities:

Primary Responsibilities

The primary responsibilities of the QS Manager are to:

- Prepare and execute system audits

- Develop internal resources

- Measure and monitor performance

- Educate other in Regulatory standards

- Participate in development of Bard policies and standards

Provide strategic direction and leadership for Quality Systems audits.

-Provide guidance to internal auditors

-Develop and implement QA educational and training programs at the facility level to promote continuous improvement in Business Operational and Quality systems

-Assure that Quality issues are identified promptly and communicated to the appropriate persons at the Division/Corporate level

-Responsible for promoting open communications between facilities and the Division/Corporate

-Develop and approve procedures and policies

Candidate Requirements:

A minimum of 4-6 years work experience in conducting audits in Medical Device and/or Pharmaceutical companies; 2 years as a Lead Auditor

Bachelor's degree in Engineering, Chemistry, Biology, or other related discipline

Knowledge and experience in Quality Tools such as Process Validation; Software Validation; Design Validation; EO Sterilization

Extensive knowledge of FDA QSR and ISO 13485:2003 standards

CQA, CQE, Lead Auditor certification preferred

Excellent communication skills - verbal and written

Strong interpersonal skills and leadership ability

Strong analytical skills

College level mathematics - knowledge of statistics

Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists. Ability to define and interpret a variety of instructions furnished in written, oral, diagram, or schedule form

Compensation:

A compensation package will be designed to attract outstanding talent and will include a base salary and an attractive benefits package.