Senior QMS Engineer # REF1965A

Company Description

KMC Systems, an Elbit Systems of America company, offers an ecosystem of engineering and innovation to develop the most advanced clinical and operational solutions for leading medical device customers across a diverse range of market segments. KMC was established in Merrimack, NH, in 1980, conveying almost half a century of innovation, R&D of next generation devices, and the agility to evolve to meet changing market dynamics. This has kept KMC at the forefront of technological advancements and as the premier choice for leading global medical device and healthcare companies. KMC is a full-suite provider with services in: Engineering Design, Manufacturing, Product Ideation, Product Lifecycle Management, and Sustaining Engineering. We are looking for extraordinary people to join #OneTeamOneMission to create and deliver innovative solutions that protect and save lives.

Job Description

As a Senior Quality Management System (QMS) Engineer in the medical device sector, you will play a vital role in overseeing the development, implementation, and maintenance of our Quality Management System. This position requires a deep understanding of industry-specific regulations and standards such as ISO 13485, FDA 21 CFR Part 820, and the European MDR. Your expertise will be instrumental in ensuring our products consistently meet the highest quality and safety standards, thus maintaining our commitment to excellence in the healthcare industry. You will be accountable for supporting the continued development, improvement, and expansion of the Quality Management System and maintaining compliance with regulations, standards, and Corporate requirements. You will be responsible for providing collaborative support to quality system leadership. You will work with other organizational functions, including Operations, Quality, R&D, procurement, corporate functions, regulatory agencies, and suppliers.

Principal Responsibilities

1. Conduct management review meetings to evaluate the effectiveness of the QMS, presenting data-driven insights on quality performance, audit outcomes, and more to top management.
2. Provide strategic recommendations based on management review findings to drive continuous improvement and reporting of review outcomes to relevant stakeholders.
3. 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.
4. Lead and execute comprehensive internal audits to assess compliance with QMS requirements, ensuring consistent adherence to internal standards and regulatory guidelines.
5. 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.
6. 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.
7. Regularly update QMS documentation to reflect changes arising from CAPA investigations and ensure continuous compliance with evolving quality system standards and regulatory requirements.
8. Assist in drafting customer quality agreements and program manufacturing/ quality plans.
9. 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
10. Participates in Six Sigma improvement projects, including coaching and development of employees.

Qualifications

• 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.

Additional Information

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
• 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

It has been and will continue to be the policy of Elbit Systems of America to recruit, hire, train, and promote into all job levels based solely upon job-related qualifications without regard to race, color, religion, creed, age, sex, national origin, gender identity or expression, sexual orientation, disability, marital status, veteran or military status, genetics or citizenship status. 

EEO STATEMENT:

Elbit Systems of America is proud to be an Equal Opportunity Employer of Minorities/Females/Protected Veterans/Individuals with Disabilities/Sexual Orientation/Gender Identity. Your information will be kept confidential according to EEO guidelines.

ACCESSIBILITY:

Elbit Systems of America is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email [email protected].

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