Senior Quality Engineer

Job Description

• Strong understanding of Medical Device Quality Systems and regulatory compliance requirements
• Working knowledge of ISO 13485:2016/2019 and 21 CFR Part 820 (FDA Quality System Regulation)
• Strong expertise in design transfer activities, including DHF → DMR transition and compliance with FDA 21 CFR 820 & ISO 13485
• Sound knowledge of Medical Device Regulations, including MDD and MDR
• Proven experience in Non Conformance (NC) management, CAPA processes, and internal/external audits
• Expertise in Medical Device Risk Management, with the ability to identify both apparent and less obvious risks
• Practical experience with Application, Process, Design, and System FMEA methodologies
• Proficient in statistical tools and techniques, including Design of Experiments (DOE)
• Capable of performing advanced descriptive and non parametric statistical analyses
• Experienced in leveraging advanced statistical methods for reliability prediction and data driven decision making
• Lead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing readiness.
• Own multiple subassemblies for a surgical robotics platform, ensuring design integrity, quality, and manufacturability.
• Investigate non-conformances (NCs) using root cause analysis and drive CAPA within the QMS framework.
• Develop and maintain FMEAs, support risk mitigation, and lead manufacturing issue resolution and qualifications (IQ/OQ/PQ).
• Identify and implement compliant, alternative solutions to engineering and production challenges while driving continuous improvement.
• Support and maintain Quality Management System (QMS) processes in compliance with regulatory requirements
• Collaborate with cross functional teams to deliver quality compliant outcomes
• Interpret and apply medical device regulations and standards to projects and processes
• Support audits and regulatory inspections, ensuring timely closure of actions

• Strong understanding of Medical Device Quality Systems and regulatory compliance requirements
• Working knowledge of ISO 13485:2016/2019 and 21 CFR Part 820 (FDA Quality System Regulation)
• Strong expertise in design transfer activities, including DHF → DMR transition and compliance with FDA 21 CFR 820 & ISO 13485
• Sound knowledge of Medical Device Regulations, including MDD and MDR
• Proven experience in Non Conformance (NC) management, CAPA processes, and internal/external audits
• Expertise in Medical Device Risk Management, with the ability to identify both apparent and less obvious risks
• Practical experience with Application, Process, Design, and System FMEA methodologies
• Proficient in statistical tools and techniques, including Design of Experiments (DOE)
• Capable of performing advanced descriptive and non parametric statistical analyses
• Experienced in leveraging advanced statistical methods for reliability prediction and data driven decision making

• Lead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing readiness.
• Own multiple subassemblies for a surgical robotics platform, ensuring design integrity, quality, and manufacturability.
• Investigate non-conformances (NCs) using root cause analysis and drive CAPA within the QMS framework.
• Develop and maintain FMEAs, support risk mitigation, and lead manufacturing issue resolution and qualifications (IQ/OQ/PQ).
• Identify and implement compliant, alternative solutions to engineering and production challenges while driving continuous improvement.
• Support and maintain Quality Management System (QMS) processes in compliance with regulatory requirements
• Collaborate with cross functional teams to deliver quality compliant outcomes
• Interpret and apply medical device regulations and standards to projects and processes
• Support audits and regulatory inspections, ensuring timely closure of actions

Salary Range: $120,000- $140,000 a year

• Discretionary Annual Incentive.
• Comprehensive Medical Coverage:
  Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
• Family Support:
  Maternal & Parental Leaves.
• Insurance Options:
  Auto & Home Insurance, Identity Theft Protection.
• Convenience & Professional Growth:
  Commuter Benefits & Certificatio n & amp;
  Training Reimbursement.
• Time Off:
  Vacation, Time Off, Sick Leave & Holidays.
• Legal & Financial Assistance:
  Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

BACHELOR OF COMPUTER SCIENCE