Quality Assurance Specialist (Auditor)

SCOPE:
This position works with management on quality short/long term planning supporting and providing diagnosis of quality problems whether internally or externally.  Manage corrective and preventive action programs and work on continuous improvement programs.  Lead and/or participate in Quality System auditing for both internal and external customers.
 
JOB RELATIONSHIPS
Reports to Director, Quality Assurance & Regulatory Affairs
 
ESSENTIAL JOB FUNCTIONS:
1.      Understand, support and follow the Corporate Vision, Mission & Values Statements.
 
2.      Support company goals and objectives.
 
3.      Understand, follow and support the policies, procedures, QSR, FDA, ISO, IEC, UL, and CE regulations.
 
4.      Coordinate and support the internal audit program, providing quality assurance and compliance activities that are in accordance with current domestic and international requirements.
 
5.      Participate in and/or manage the internal quality auditing system including planning and reporting
 
6.      Participate in and/or manage corrective and preventative action processes for both internal and external suppliers.
 
7.      Participate in the development and implementation of new procedures for plant quality systems (ISO and QSR), consistent with OSI policies and procedures, including federal and international regulations.
 
8.      May provide direct assistance and on design projects for new product introduction ensuring advanced compliance with internal and external requirements.
 
9.      Develop audit schedules, compile audit plans using established procedures.
 
10.  Maintain existing Quality System; generates reports of trend analysis and statistical distribution for manufacturing process audits and product audits.
 
11.  Implement change and review current processes throughout the organization to enhance overall performance.
 
12.  Participate as an interface and coordinator between departments to assure harmonization of Quality System documentation.
 
13.  Participate in Quality Systems training.
 
14.  Perform other related duties as assigned.
 
PHYSICAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Duties are performed while sitting at a desk for long periods of time. Required duties include operating a computer, reading, writing and using a telephone. Walking or standing within the office area may be required for the operation of office equipment and for attending meetings.  Bending, stooping and kneeling occasionally may be required.   The employee may be required to lift 25 pounds.
 
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Job duties are performed in an office environment utilizing standard office equipment such as a computer, photocopier, and telephone.  The noise level in the work environment is usually moderate to high.  Within the Production/Assembly floor or at Supplier sites, the employee may be exposed to sharp objects, small tools, hot objects, adhesives, UV light, various testing equipment, isopropyl alcohol, soldering equipment, and other machinery, etc. 
Requirements
 
KNOWLEDGE, SKILLS AND ABILITIES:
 
1.      Proficiency with Microsoft Word, Excel and Access.
 
2.      Ability to interact with all levels of employees and management effectively. 
 
3.      Excellent verbal and written communication skills.
 
4.      Certified Auditor by the American Society for Quality (ASQ) or equivalent.
 
5.      Working knowledge of handling internal auditing, complaints and CAPA implementation.
 
6.      Ability to be a team player and show commitment to continuous improvement
 
7.      Ability to apply good English grammar and style in procedures, processes and reports.
 
8.      Ability to review and interpret engineering drawings
 
9.      Ability to operate office computer applications for reports, spreadsheets and statistical analysis.
 
EDUCATION AND EXPERIENCE:
 
 
HS diploma and 2 - 4 YOE
 
 
 
NO RELOCATION ASSISTANCE AVAILABLE.
Please email resume for consideration to Yvonne Robles, This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .