Quality Systems Specialist II

Company Description

Elbit Systems of America is a leading provider of high-performance products, system solutions, and support services focusing on the defense, homeland security, commercial aviation, and medical instrumentation markets. With facilities throughout the United States, Elbit Systems of America is dedicated to supporting those who contribute daily to the safety and security of the United States. Elbit Systems of America, LLC is wholly owned by Elbit Systems Ltd. (NASDAQ: ESLT and TASE: ESLT), a global high technology company engaged in a wide range of programs for innovative defense and commercial applications. For additional information, visit: www.elbitsystems-us.com or follow us on Twitter.

Job Description

MAJOR JOB OBJECTIVES

Support Quality Systems and Quality Assurance Operations by fulfilling Quality System duties as assigned. Quality System roles can vary, however, they support return materials, investigations, document control, change control, complaint handling, record control and training. Additional compliance activities may be assigned with sufficient training. Assure Quality System policies, standards, instructions, and procedures are completed with Good Documentation Practices and in a timely manner.  Acts as a support member during FDA Inspections and other regulatory/customer audits.

PRINCIPAL RESPONSIBILITIES

1. Support document lifecycle management through the quality system.
2. Support QMS training by creating assignment profiles, creating curriculums, assigning trainings, and running reports for management.
3. With document owners ensure periodic document reviews are completed timely.
4. Support QS department by assisting with document change orders and document reviews and approvals.
5. Update or create documents to include process flow diagrams, roles and responsibilities tables, and appendices.
6. Create and manage job aids or work instructions as applicable.
7. Support QMS Management with records retention, QMS records, and standards library.
8. Support QMS Management with monthly Quality System training events.
9. Document QMS records as applicable such as RMAs, CAPAs, Complaints, DCOs, Quality System Documents, Training and Change Control items.

Qualifications

Entry level position in the Quality Assurance function. High School diploma or equivalent required.  Associates degree in Liberal Arts, Business preferred.  BS degree in a technical major a plus

Candidates must desire the willingness to learn and understand regulatory requirements.  

Good work ethic, able to follow multipart instructions and break down larger objectives into manageable tasks to deliver on commitments. Ability to think out of the box, work independently and as part of a team.  Attention to detail and good communication skills required.  

Good computer skills especially word, pdf writer, excel, and power point.  Willingness to learn QMS related systems such as Pilgrim, Trackwise, Team Center etc.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Here Are Some of the Great Benefits We Offer:

• Most locations offer a 9/80 schedule providing every other Friday off
• Competitive compensation & 401k program to plan for your future
• Robust medical, dental, vision, & disability coverage with qualified wellness discounts
• Basic Life Insurance and Additional Life & AD&D Insurances are available
• Flexible Vacation & PTO
• Hybrid or Remote work options at many locations
• Paid Parental Leave
• Generous Employee Referral Program
• Voluntary Benefits Available: Longer Term Care, Legal, Identify Theft, Pet Insurance, and many more options
• Voluntary Tricare Supplement available for military retirees

#LI-AP1