Medical Device Quality Engineer

Marmon Holdings, Inc.; Charlottesville (VA); Presencial; USD 75 000 - 105 000; Tempo integral

Resumo da oferta

MicroAire Surgical Instruments LLC, part of Marmon Holdings, seeks Quality Engineers to support new product development, sustaining engineering, supplier quality, and QMS initiatives. The role spans design controls, validation, and regulatory compliance within a regulated medical device environment.

Depending on experience, hire at Quality Assurance Engineer or Senior level, leading CAPA, risk management, and quality improvement projects while collaborating across R&D, Manufacturing, Regulatory

Qualificações

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• 0 to 3 years of quality, manufacturing, or engineering experience.
• Knowledge of FDA, ISO 13485, CAPA, validation, and quality systems preferred.

Responsabilidades

• Support and/or lead quality engineering activities related to new product development, design control, and sustaining engineering programs.
• Participate in design verification, design validation, risk management, process validation, packaging validation, sterilization validation, and design transfer activities.
• Develop, execute, and review validation and qualification protocols and reports, including IQ/OQ/PQ activities.
• Ensure compliance with applicable FDA regulations, ISO standards, company procedures, and other regulatory requirements.
• Support and/or lead CAPA, complaint investigations, nonconformance investigations, root cause analysis, and corrective action activities.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, Supply Chain, and Operations teams to drive quality objectives and support product launches.
• Support supplier quality activities including supplier qualification, audits, incoming quality issues, and material discrepancy resolution.
• Utilize statistical analysis and data-driven decision-making to evaluate process capability, quality trends, and product performance.

Conhecimentos

FDA and ISO 13485 compliance

Quality systems

CAPA management

Change control

Audit support

Design controls

Formação académica

Bachelor's degree in Engineering, Science, or related

Descrição da oferta de emprego

MicroAire Surgical Instruments LLC, part of Marmon Holdings, seeks Quality Engineers to support new product development, sustaining engineering, supplier quality, and QMS initiatives. The role spans design controls, validation, and regulatory compliance within a regulated medical device environment.

Depending on experience, hire at Quality Assurance Engineer or Senior level, leading CAPA, risk management, and quality improvement projects while collaborating across R&D, Manufacturing, Regulatory