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Quality Systems Auditor
Ref No.: 18-02010
Location: Murray Hill, New Jersey
Position Type:Contract
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:401K, Dental Insurance, Life Insurance, Medical Insurance, Vision Insurance
Hiring a Contract Quality Systems Auditor
Duration:  1 year
Client Location:  Murray Hill, NJ
Work Schedule:  40 Hours Weekly
Pay Rate:  $30.00 Hourly
Benefits: ACA Compliant Medical Insurance

The Quality Systems Auditor is accountable for the tracking and execution of quality systems audits. This position will help drive the implementation of a standardized quality system process for supplier management, as well as facilitate the development and execution of the supplier audit plan for MPS integration.
  • Consistent application of Quality system standards to assigned Quality system area
  • Develops solutions to routine assigned activities of moderate scope & complexity
  • Follows applicable Company / Unit procedures and may make updates to procedures and policies
  • Works within and across functions for assigned Quality systems • Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements
  • Subject Matter expert / Super User at site for assigned quality system
  • Guides the successful completion of major programs and may function in a project leadership role Position specific responsibilities include support of the following, however are not limited to:
    • Quality Systems (Medication & Procedural Solutions (MPS), Franklin Lakes) -
    • Supplier Audits:  Performs audits of MPS suppliers  Coordinates execution of the supplier management integration plan to ensure execution of all required audits as well as timely implementation of corrective actions and closure of audits
    • General:  Develops training content and provides quality systems related training at unit and Plant locations  Maintains and improves the Franklin Lakes and WW Quality System documentation  Tracks integration project progress and provides periodic reports
Qualifications
  • Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD, Canadian MDR.
  • In-depth understanding of the application of quality systems to the medical device industry.
  • Industry recognized certification in a Quality System element specialty (e.g. ASQ Certified Quality Auditor, Quality Engineer) preferred.
  • Supplier auditing experience required.
  • TrackWise, technical writing experience preferred.
  • Prior experience managing external regulatory audits preferred.
  • Excellent communication skills at all levels both written and verbal.
  • Ability to perform multiple tasks and prioritize work load.
  • Effective analytical, technical, and problem solving skills.
  • Effective meeting and presentation skills.
  • Self-motivated /directed.
To Apply for immediate consideration please send resume to Louis Moliterno at Louis.Moliterno@onboardusa.com and reference job # 18-02010 in the Subject Line and indicate the best times to contact you (please include nights and weekends if needed).

**Candidates must complete background and drug screenings before starting any assignment.

On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.