Staff Quality Compliance Engineer, Medical Devices

PROCEPT BioRobotics Corporation; San Francisco (CA); On-site; USD 130,000 - 190,000; Full time

Job summary

PROCEPT BioRobotics Corporation is seeking a Staff Engineer for Quality Compliance and Post-Market Surveillance. You will lead strategic initiatives to enhance the quality system, monitor metrics, and collaborate with cross-functional teams to ensure regulatory alignment.

The role emphasizes CAPA execution, risk assessment, and continuous improvement within a fast-paced medical device environment. The position requires a strong background in quality systems, regulatory knowledge (FDA QSR/QMSR,

Qualifications

• Bachelor’s degree in engineering, science, or another technical discipline.
• 8 years of progressive experience in a medical device industry, including at least 5 years in quality systems, quality engineering, and/or compliance roles.
• Working knowledge of FDA QSR/QMSR, ISO 13485, MDSAP, and EU MDR regulatory requirements.
• Working knowledge of computer software validation principles, including in-device software, GxP systems, and 21 CFR Part 11.
• Demonstrated ability to lead project teams and deliver results within aggressive timelines.
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to clearly convey complex concepts to diverse audiences.
• Ability to apply conceptual and systems thinking to understand complex issues and downstream implications.
• Proven ability to collaborate effectively in a fast-paced, matrixed environment.
• Ability to travel up to 10% as required.

Responsibilities

• Lead and manage special projects for the Quality Compliance and Post-Market Surveillance team.
• Identify process risks and opportunities within the QMS and implement sustainable solutions.
• Serve as a Quality Compliance and Post-Market Surveillance representative on cross-functional initiatives.
• Perform and lead CAPA, including root cause investigations and corrective actions.
• Define key performance requirements for processes and projects and monitor effectiveness.
• Review regulations to ensure products and processes remain compliant.
• Apply data-driven analysis and pragmatic problem-solving within regulatory constraints.
• Drive cross-functional collaboration among SME and stakeholders.
• Demonstrate leadership through technical competence and independent decision-making.
• Maintain trained status and comply with QMS and EHS policies.

Skills

Analytical skills

Communication skills

Problem-solving

Project leadership

Quality systems

Regulatory knowledge

Education

Bachelor's degree in engineering, science, or another technical discipline

Master’s degree in engineering, science, or another technical discipline

Tools

GxP systems

21 CFR Part 11

Software validation

QMS software

Job description

PROCEPT BioRobotics Corporation is seeking a Staff Engineer for Quality Compliance and Post-Market Surveillance. You will lead strategic initiatives to enhance the quality system, monitor metrics, and collaborate with cross-functional teams to ensure regulatory alignment.

The role emphasizes CAPA execution, risk assessment, and continuous improvement within a fast-paced medical device environment. The position requires a strong background in quality systems, regulatory knowledge (FDA QSR/QMSR,