Onsite Quality Engineer - Medical Devices

Actalent; Warsaw (IN); Presencial; USD 55 000 - 80 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental & vision

401(k) Retirement Plan

HSA

Resumo da oferta

Actalent in Warsaw, IN is seeking a Quality Engineer to drive data‑driven quality improvements in a regulated medical device environment. You will conduct audits, inspections, and tests, collaborate with Manufacturing, Sourcing, and Development, and lead projects with realistic timelines to ensure products meet standards.

The role requires hands‑on experience in ISO and QSR compliance, root cause analysis, and auditing, with an emphasis on cross‑functional teamwork and continuous improvement.

Qualificações

• Quality engineering experience in a regulated environment.
• Experience with ISO standards and QSR requirements.
• Experience with audits, inspections, and tests.
• Analysis of processes to ensure compliance and performance.

Responsabilidades

• Gathers data to identify and solve quality problems.
• Plans and leads quality projects with realistic timelines.
• Evaluates processes and equipment for performance and quality.
• Establishes quality plans for equipment and processes.
• Monitors processes against standards and acts on deviations.
• Ensures products conform to requirements via audits and tests.
• Collaborates with suppliers and internal teams on quality.
• Interprets regulations with Manufacturing, Sourcing, and Development.
• Maintains budgets for quality engineering activities.
• Fosters a team-oriented environment across departments.

Conhecimentos

Quality engineering

Medical device quality

ISO & QSR knowledge

Project planning

Cross-functional collaboration

Data-driven decision making

Audits and inspections

Root cause analysis

Formação académica

Bachelor of Science in Engineering or CQE

Descrição da oferta de emprego

Actalent in Warsaw, IN is seeking a Quality Engineer to drive data‑driven quality improvements in a regulated medical device environment. You will conduct audits, inspections, and tests, collaborate with Manufacturing, Sourcing, and Development, and lead projects with realistic timelines to ensure products meet standards.

The role requires hands‑on experience in ISO and QSR compliance, root cause analysis, and auditing, with an emphasis on cross‑functional teamwork and continuous improvement.