Senior Quality Engineer – Med Devices & NPD Lead

Default (MSD); Maryland; Presencial; USD 101 000 - 155 000; Tempo integral

Resumo da oferta

MSD in Maryland seeks a Quality Engineer III to lead and mentor QA activities, directing development, application and improvements to quality systems for processes, materials and products. The role ensures compliance with company quality programs and regulatory certifications, while guiding teams in validation and CAPA efforts.

The candidate will participate in NPD, oversee supplier quality, and drive data-driven improvements across the QMS, with strong emphasis on ISO 9001, QSR and ISO 13485

Qualificações

• Bachelor’s degree in a technical/scientific/engineering discipline is required.
• Master’s degree is preferred.
• Minimum of 7 years of experience in medical devices or related field.
• Experience with developing, implementing and maintaining Quality System compliance.
• Experience planning and implementing quality plans and programs.
• Experience in mentoring/training preferred.
• ASQ certification or equivalent beneficial; Lean Six Sigma experience preferred.
• ISO 9001, FDA QSR, ISO 13485 knowledge advantageous.

Responsabilidades

• New Product Development participation on NPD project teams.
• Ensure compliance to QMS and guide design controls.
• Review design/development documents for conformance.
• Oversee design history files and risk management files.
• Lead supplier quality investigations for NPD projects.
• Lead internal and supplier audits and CAPA processes.
• Generate metrics to measure QMS effectiveness.

Conhecimentos

Statistics

Lean Six Sigma

QMS experience

Project organization

Communications

Documentation skills

MS Office

Mentoring

Regulatory knowledge

Multi-tasking

Formação académica

Bachelor’s degree in technical/scientific/engineering

Master’s degree preferred

ASQ CQE/CRE/CQA beneficial

Descrição da oferta de emprego

MSD in Maryland seeks a Quality Engineer III to lead and mentor QA activities, directing development, application and improvements to quality systems for processes, materials and products. The role ensures compliance with company quality programs and regulatory certifications, while guiding teams in validation and CAPA efforts.

The candidate will participate in NPD, oversee supplier quality, and drive data-driven improvements across the QMS, with strong emphasis on ISO 9001, QSR and ISO 13485