OS 5262 (VOS) Quality Systems Manager

Varian Medical Systems, located in Palo Alto, California, is the world's leading manufacturer of radiotherapy systems, which are treating thousands of cancer patients per day. The company is also a premier supplier of X-ray tubes and flat-panel digital subsystems for imaging in medical, scientific, and industrial applications. VMS currently employs over 3,600 people who are located at manufacturing sites in North America and Europe and in 56 sales and support offices around the world. The company?s gross revenues reached $1.38 billion for fiscal year 2005.  Please visit our website at www.varian.com for additional information.

Job Description:

 

1. Responsible for the management of Internal Audit Program for all VOS manufacturing facilities.

2. Responsible for the maintenance of the Quality Manual.

3. Responsible for the coordination of external agency inspections for all VOS manufacturing facilities.

4. Liaison between Varian Oncology Systems and regulatory agencies.

5. Overall responsibility for ensuring compliance with ISO and FDA regulatory requirements, as applicable to VOS business needs.

6. Provide technical support to the operations groups in troubleshooting and process/technology development and continuous improvement programs.

7. Support quality input in Product Line Transfer initiatives, ensuring products are transferred and meet quality, compliance and customer requirements.

8. Perform quality systems review meetings to ensure follow-up of issues and implementation of Corrective and Preventative actions.

9. Educate, train, coach and evaluate direct reports, ensuring retention of key staff.

10. Responsible for the harmonization of all regulatory business practices across all VMS business units.

11. Responsible for the development of budgets, policies and procedures

12. Responsible for the hiring, training, assessment, and management of employees and contracted resources.

13. Works with Corporate RA on the strategy and development of company-wide business regulatory practices and policies.

 

Qualifications:

 

1. BS or MS in Life Sciences required plus 8 years of experience in managing a regulatory affairs department.

2. Knowledge of FDA (21 CFR Part 820,  ISO 13485, ISO 14971 and other medical device regulations, both domestic and international)

3. Requires excellent written and verbal communications.

4. Familiarity with radiotherapy equipment and software. (desired)

5. Must be able to interact well with all levels of management, co-workers, and regulators.

6. Good interpersonal and negotiating skills.

7.  Excellent skills with Micro Office (Word, Excel, and PowerPoint); SAP experience a plus.

 

VARIAN MEDICAL SYSTEMS is firmly committed to a policy of equal employment opportunity and will administer its Human Resources policies and conduct its employment practices in a manner that treats each employee and applicant for employment on the basis of merit, experience, and other work-related criteria without regard to race, color, religion, sex, national origin, ancestry, sexual orientation, age, marital status, medical, disability (mental or physical), veteran status, or any other protected class under relevant state and federal laws.