Sr. Quality Engineer

Katalyst CRO; Santa Clara (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking an experienced Senior Quality Engineer with expertise in Medical Device Quality Engineering and Regulatory Compliance. The ideal candidate will have hands-on experience in medical device quality systems, risk management, complaint handling, post-market surveillance, CAPA, and regulatory compliance.

This role supports product development, manufacturing, validation, and quality assurance activities while ensuring compliance with FDA regulations, ISO standards, and global

Qualifications

• Bachelor's degree in mechanical engineering or a related engineering discipline.
• ASQ Certified Quality Engineer (CQE) certification is preferred.
• Minimum 6 years of experience in the Medical Device industry.
• Experience working in highly regulated manufacturing environments.
• Experience supporting product development, manufacturing, and quality engineering activities.
• Experience managing complaint handling and Post Market Surveillance (PMS) activities.
• Experience managing Non-Conformance (NC), CAPA, and quality investigations.
• Experience supporting internal, external, and regulatory audits.

Responsibilities

• Lead design transfer and production support activities while ensuring compliance with FDA regulations and ISO 13485 requirements.
• Support manufacturing readiness and quality initiatives throughout product development programs.
• Manage quality activities for assigned product components and subassemblies to ensure design integrity and manufacturability.
• Investigate non-conformances using root cause analysis and drive CAPA implementation within the Quality Management System (QMS).
• Develop, maintain, and update Design, Process, Application, and System FMEAs while supporting risk mitigation activities.
• Support qualification and validation activities, including IQ, OQ, and PQ.
• Identify, evaluate, and implement compliant solutions for engineering and manufacturing challenges.
• Maintain and continuously improve Quality Management System (QMS) processes.
• Collaborate with Engineering, Manufacturing, Operations, and Quality teams to resolve product and process issues.
• Interpret and apply FDA regulations, ISO standards, and medical device quality requirements throughout the product lifecycle.
• Support internal, external, customer, and regulatory audits and ensure timely closure of audit findings.
• Utilize statistical tools and data analysis techniques to improve product quality, reliability, and manufacturing processes.
• Ensure compliance with medical device quality standards and regulatory requirements across all quality engineering activities.

Skills

Medical Device Quality Systems

ISO 13485

FDA 21 CFR Part 820

Risk Management ISO 14971

CAPA

Quality Assurance

Design Transfer

Statistical Methods

Education

Bachelor's degree in mechanical engineering

ASQ CQE certification

Tools

QMS

Job description

• We are seeking an experienced Senior Quality Engineer with expertise in Medical Device Quality Engineering and Regulatory Compliance. The ideal candidate will have hands-on experience in medical device quality systems, risk management, complaint handling, post-market surveillance, CAPA, and regulatory compliance.
• This role supports product development, manufacturing, validation, and quality assurance activities while ensuring compliance with FDA regulations, ISO standards, and global medical device requirements.
• Lead design transfer and production support activities while ensuring compliance with FDA regulations and ISO 13485 requirements.
• Support manufacturing readiness and quality initiatives throughout product development programs.
• Manage quality activities for assigned product components and subassemblies to ensure design integrity and manufacturability.
• Investigate non-conformances using root cause analysis and drive CAPA implementation within the Quality Management System (QMS).
• Develop, maintain, and update Design, Process, Application, and System FMEAs while supporting risk mitigation activities.
• Support qualification and validation activities, including IQ, OQ, and PQ.
• Identify, evaluate, and implement compliant solutions for engineering and manufacturing challenges.
• Maintain and continuously improve Quality Management System (QMS) processes.
• Collaborate with Engineering, Manufacturing, Operations, and Quality teams to resolve product and process issues.
• Interpret and apply FDA regulations, ISO standards, and medical device quality requirements throughout the product lifecycle.
• Support internal, external, customer, and regulatory audits and ensure timely closure of audit findings.
• Utilize statistical tools and data analysis techniques to improve product quality, reliability, and manufacturing processes.
• Ensure compliance with medical device quality standards and regulatory requirements across all quality engineering activities.

Job Summary

• We are seeking an experienced Senior Quality Engineer with expertise in Medical Device Quality Engineering and Regulatory Compliance. The ideal candidate will have hands-on experience in medical device quality systems, risk management, complaint handling, post-market surveillance, CAPA, and regulatory compliance.
• This role supports product development, manufacturing, validation, and quality assurance activities while ensuring compliance with FDA regulations, ISO standards, and global medical device requirements.

Roles & Responsibilities

• Lead design transfer and production support activities while ensuring compliance with FDA regulations and ISO 13485 requirements.
• Support manufacturing readiness and quality initiatives throughout product development programs.
• Manage quality activities for assigned product components and subassemblies to ensure design integrity and manufacturability.
• Investigate non-conformances using root cause analysis and drive CAPA implementation within the Quality Management System (QMS).
• Develop, maintain, and update Design, Process, Application, and System FMEAs while supporting risk mitigation activities.
• Support qualification and validation activities, including IQ, OQ, and PQ.
• Identify, evaluate, and implement compliant solutions for engineering and manufacturing challenges.
• Maintain and continuously improve Quality Management System (QMS) processes.
• Collaborate with Engineering, Manufacturing, Operations, and Quality teams to resolve product and process issues.
• Interpret and apply FDA regulations, ISO standards, and medical device quality requirements throughout the product lifecycle.
• Support internal, external, customer, and regulatory audits and ensure timely closure of audit findings.
• Utilize statistical tools and data analysis techniques to improve product quality, reliability, and manufacturing processes.
• Ensure compliance with medical device quality standards and regulatory requirements across all quality engineering activities.

Requirements

• Bachelor's degree in mechanical engineering or a related engineering discipline.
• ASQ Certified Quality Engineer (CQE) certification is preferred.
• Minimum 6 years of experience in the Medical Device industry.
• Experience working in highly regulated manufacturing environments.
• Experience supporting product development, manufacturing, and quality engineering activities.
• Experience managing complaint handling and Post Market Surveillance (PMS) activities.
• Experience managing Non-Conformance (NC), CAPA, and quality investigations.
• Experience supporting internal, external, and regulatory audits.

Technical Skills

• Strong knowledge of Medical Device Quality Systems.
• Hands-on experience with ISO 13485:2016/2019.
• Strong knowledge of FDA 21 CFR Part 820.
• Knowledge of Medical Device Regulations (MDD/MDR).
• Experience with Medical Device Risk Management (ISO 14971).
• Experience with Design, Process, Application, and System FMEA.
• Experience with Quality Management Systems (QMS).
• Experience supporting IQ, OQ, and PQ qualification activities.
• Proficiency in Design of Experiments (DOE).
• Experience performing descriptive and non-parametric statistical analysis.
• Experience with reliability analysis and statistical data interpretation.
• Strong knowledge of Regulatory Compliance and Medical Device Quality practices.