Senior Quality Engineer-Medical Device

Company Information

At HiArc, we believe clients don’t need another vendor; they need a strategic partner who gets it. One who listens harder, thinks deeper, and builds smarter—around their needs, products, and goals. HiArc engineers and manufactures complex medical technologies with one goal in mind: creating the perfect fit for our clients. No off-the-shelf thinking. No compromises. Just a tailored, high-performance solution our clients need, the way they need it. That’s why HiArc is the most client-centered partner in the market. We fuse design, engineering, and manufacturing into a seamless, collaborative process—crafted entirely around our clients. We operate as an extension of our clients' teams, de-risking their processes and accelerating their path to market. And the result is a solution you won’t find anywhere else.

Join our team! We hire experts in hardware and software design, robotics, optics, fluidics, chemistry integration, motion and thermal control, risk management, supply chain management, performance testing, advanced manufacturing techniques, finance, human resources, sales, and marketing.

For more information, please visit HiArc.

We are currently recruiting for a Senior Quality Engineer, but we are looking for more than an impressive skill set. We are looking for the type of person who respects others for their knowledge, skills, and experience as individuals and as team members. If you are the type of person who has high integrity and would thrive in an inclusive environment of camaraderie and friendship with your fellow teammates, we’re pretty confident you’ll love it here

Responsibilities

• Plan, devise and implement Quality Assurance standards, instructions, and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment for an assigned complex project or area to assure the highest quality levels and cost‑effective compliance with contractual and HIARC requirements. Develop test techniques and procedures as required.
• Assist in planning, devising and implementing Quality Assurance standards, instructions, and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment for an assigned project or area to assure the highest quality levels and cost‑effective compliance with contractual and Company requirements.
• Apply basic engineering and scientific principles and techniques to assist in the development and establishment of quality assurance programs which provide and maintain the highest quality levels for an assigned project, product, or area.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of assigned products or production equipment.
• Conduct experiments and audits to evaluate operating characteristics of products or processes. Evaluate data from experiments and prepare reports and summaries outlining results and recommend revisions or modifications to the product or process to maintain or improve product quality.
• Support customer and regulatory audits and assist in completing corrective actions to resolve any findings from audits
• Assist in evaluating producibility and reliability of the finished product, ensuring that all established standards and regulations are met. Assist in determining equipment to be used to maximize manufacturing effectiveness and minimize cost.
• Assist in complete failure analysis investigations to determine the root cause and take appropriate corrective action to revise design, methods and inspection/test instructions to prevent failure recurrence.
• Evaluate and monitor quality of vendor services and goods and recommend selection of optimum vendors.
• Serve as member of Material Review and Configuration Control Boards.
• Support the manufacturing process in resolving design problems, assist in the transition of products from development into production.
• Review and assess Engineering Change Orders (ECOs) for design and process changes to ensure compliance with quality and regulatory requirements.
• Collaborate with cross-functional teams to provide quality input for verification and validation activities
• Lead investigations, root cause analysis, and corrective action implementation to ensure timely closure of customer complaints.
• Manage RMA process from product return through evaluation and disposition, driving trend analysis, and systemic issue resolution.
• Prepare and present quality performance metrics and dashboards to support program reviews and leadership decisions.
• Support MES configuration and data integrity to ensure accurate quality record capture and compliance
• Monitor use of test equipment to assure efficient utilization. Recommend corrective action relative to design, application, or procedures.
• Evaluate test specifications and test equipment for purposes of improving current methods and operations. Perform initial tests with equipment and instruct test personnel in its use.
• Provide instruction to others in the fabrication and operation of test equipment, and in the interpretation of test procedures.
• Perform special studies and assignments as designated.
  
  

Qualifications

• A Bachelor's degree in a technical discipline and 5 years of related experience to be proficient in the above areas; or an equivalent combination of education and experience.
• Prior experience in Medical Device or Pharmaceutical manufacturing support. FDA and ISO audit experience (13485, 21 CFR 820, 803, 806 and 14971) is preferred.
• Green Belt/Black Belt proficiency desired or CQE.
• ISO 13485:2016 Lead auditor certification preferred
• Hands on experience working with MES for production traceability
• Proficiency in PLM systems for managing change control and documentation
• Proficiency in data analytics tools such as Minitab, Tableau, PowerBI etc.
  
  

Here Are Some Of The Great Benefits We Offer

• Most locations offer a 9/80 schedule, providing every other Friday off
• Competitive compensation & 401(k) 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 more
• Voluntary Tricare Supplement available for military retirees
  
  

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. The employer has the right to revise this job description at any time. The job description is not an employment contract. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. HiArc, an Elbit America company, is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.

• If you encounter issues with your application, please email TalentAcquisition@ElbitAmerica.com***