Staff Quality Compliance Engineer
PROCEPT BioRobotics
full-time
Posted on:
Location Type: Hybrid
Location: San Jose • California • United States
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Salary
💰 $144,000 - $169,000 per year
Job Level
About the role
- Lead and manage special projects for the Quality Compliance and Post-Market Surveillance team, including planning, execution, and delivery of strategic initiatives and continuous improvement efforts.
- Proactively identify process risks and improvement opportunities within the Quality Management System (QMS), leveraging a deep understanding of cross-functional interdependencies to implement sustainable, effective solutions.
- Serve as a Quality Compliance and Post-Market Surveillance team representative on cross-functional initiatives, operating independently while influencing stakeholders and coordinating activities to meet project objectives.
- Perform and lead Corrective and Preventive Actions (CAPA), including conducting thorough root cause investigations and developing corrective actions with appropriate scope and rigor relative to the identified quality issue.
- Define key performance requirements for processes and projects; establish monitoring mechanisms and evaluate effectiveness against defined objectives to ensure continuous improvement.
- Review and interpret regulations, standards, and guidance to ensure products, processes, and services remain compliant and aligned with state-of-the-art and regulatory expectations.
- Apply sound technical judgment, data-driven analysis, and pragmatic problem-solving within the constraints of applicable regulations, standards, and internal procedures.
- Drive cross-functional collaboration by effectively engaging subject matter experts and stakeholders to achieve aligned, timely outcomes.
- Demonstrate leadership through technical competence, influence, accountability, and independent decision-making, without direct people management responsibility.
- Maintain trained status and comply with the PROCEPT BioRobotics Quality Management System (QMS) and EHS policies.
- Perform other duties as assigned.
Requirements
- 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.
Benefits
- full medical coverage
- wellness programs
- on-site gym
- 401(k) plan with employer match
- short-term and long-term disability coverage
- basic life insurance
- wellbeing benefits
- flexible or paid time off
- paid parental leave
- paid holidays
- many more!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Management System (QMS)Corrective and Preventive Actions (CAPA)FDA QSR/QMSRISO 13485MDSAPEU MDRcomputer software validationGxP systems21 CFR Part 11data-driven analysis
Soft Skills
leadershipanalytical skillsorganizational skillsproblem-solving skillswritten communicationverbal communicationcollaborationinfluenceindependent decision-makingconceptual thinking