Senior Quality Engineer-Medical Device

Join to apply for the Senior Quality Engineer-Medical Device role at Hi Arc .

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.

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.

• 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…