Sr. Quality Management Systems Engineer # REF1965A
Elbit Systems of America
- Merrimack, NH
- Permanent
- Full-time
- Provide strategic recommendations based on management review findings to drive continuous improvement and reporting of review outcomes to relevant stakeholders.
- Act as the primary liaison for all external audits (customer, registrar, etc.) and FDA inspections, ensuring all necessary documentation and processes are readily available and in compliance.
- Lead and execute comprehensive internal audits to assess compliance with QMS requirements, ensuring consistent adherence to internal standards and regulatory guidelines.
- Address and resolve any non-conformities identified during external and internal audits, implementing corrective and preventive actions to enhance the QMS and maintain regulatory compliance.
- Lead the initiation, investigation, and resolution of Corrective and Preventive Actions (CAPAs), ensuring thorough data analysis, RCA tools, and practical solutions to prevent recurrence while maintaining alignment with quality system and regulatory requirements.
- Regularly update QMS documentation to reflect changes arising from CAPA investigations and ensure continuous compliance with evolving quality system standards and regulatory requirements.
- Assist in drafting customer quality agreements and program manufacturing/ quality plans.
- Oversee and manage unit-level quality processes using advanced Manufacturing Execution Systems (MES) like Factorylogix and Product Lifecycle Management (PLM) tools such as Siemens Teamcenter
- Participates in Six Sigma improvement projects, including coaching and development of employees.
- A BS degree in engineering or related technical discipline, plus five or more years of related experience to be proficient in the above areas; or an equivalent combination of education and experience.
- Prior experience in medical devices or pharmaceutical industries.
- Strong knowledge of ISO 13485, 21CFR 820, ISO 9001, and other applicable medical device regulations.
- Full proficiency in Microsoft Office required.
- Robust and flexible communication skills.
- Green Belt/Black Belt proficiency, Certified Quality Auditor, and Certified Quality Engineer are preferred.
- Self-motivated and directed, requiring minimal supervision.
- Effective skills in analytical thinking and problem-solving required.
- 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
- 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