Otsuka Pharmaceutical Co., Ltd
Staff Quality Engineer, CAPA
Otsuka Pharmaceutical Co., Ltd, Palo Alto, California, United States, 94306
Staff Quality Engineer, CAPA page is loaded## Staff Quality Engineer, CAPAremote type:
Onsitelocations:
Palo Altotime type:
Full timeposted on:
Posted 6 Days Agojob requisition id:
R10183At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.**Position Summary**
The Staff Quality Engineer – CAPA is responsible for leading and sustaining the Corrective and Preventive Action (CAPA) process to ensure timely, effective, and compliant resolution of quality issues. This role drives root cause analysis, risk-based decision-making, and continuous improvement initiatives while maintaining adherence to internal policies, procedures, and regulatory requirements. The individual will collaborate across functions and work independently to design, implement, and optimize quality system solutions that enhance product reliability and process performance.**Responsibilities and Duties**•
Support company goals, objectives, policies, and procedures to ensure alignment with quality and regulatory standards.
•
Lead and manage the entire CAPA lifecycle, including initiation, investigation, action planning, implementation, and effectiveness verification.
•
Serve as Subject Matter Expert (SME) for root cause analysis; provide guidance and training on structured problem-solving tools such as 5 Whys, Fishbone (Ishikawa), and Fault Tree Analysis to eliminate systemic issues.
•
Perform and support risk assessments (e.g., FMEA) and integrate risk management principles into CAPA activities and sustaining engineering changes.
•
Identify, prioritize, and implement proactive quality improvements to prevent recurrence of issues and enhance process robustness.
•
Collect, analyze, and trend CAPA and quality system metrics to identify patterns, drive continuous improvement, and report findings to management.
•
Communicate CAPA findings, progress, and outcomes effectively across cross-functional teams, ensuring transparency and accountability.
•
Create, revise, and review Standard Operating Procedures (SOPs) and related documentation to maintain compliance with latest regulatory standards
•
Assist with internal audits and management reviews, ensuring readiness for external inspections and regulatory audits.**Requirements**•
Bachelor’s degree in an engineering or related technical discipline or equivalent
•
Minimum of 7 years in Quality Assurance/Quality Engineering role within the Medical Device Industry
•
Proven experience with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
•
In depth knowledge of CAPA process, requirements and investigational techniques
•
Working knowledge of design controls, risk management, process validation, and statistical techniques.
•
Proficiency in root cause analysis tools such as Ishikawa (Fishbone) diagrams, Fault Tree Analysis, Contradiction Matrix, and 5 Whys.
•
Ability to collect, review, and interpret data for trend analysis and continuous improvement.
•
Self-motivated, able to work independently, and driven to achieve results with a sense of urgency.
•
Effective at dealing with change and ambiguity as business needs shift, demonstrating flexibility while ensuring compliance.
•
Strong written and verbal communication skills; comfortable presenting to small and large groups.
•
Proficient in Microsoft Office Suite with advanced skills in Excel, PowerPoint, Visio, and Word.**Salary Range:** $153,977 - $169,562(Annual Base Salary)The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.**Equal Employment Opportunity**
At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.Respecting your privacy is an essential part of the Company’s privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant’s application for employment, a Contract Worker’s work, or a Former Employee’s employment at Recor. Refer to our
for more detail information.remote type:
Onsitelocations:
Palo Altotime type:
Full timeposted on:
Posted 30+ Days Ago #J-18808-Ljbffr
Onsitelocations:
Palo Altotime type:
Full timeposted on:
Posted 6 Days Agojob requisition id:
R10183At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.**Position Summary**
The Staff Quality Engineer – CAPA is responsible for leading and sustaining the Corrective and Preventive Action (CAPA) process to ensure timely, effective, and compliant resolution of quality issues. This role drives root cause analysis, risk-based decision-making, and continuous improvement initiatives while maintaining adherence to internal policies, procedures, and regulatory requirements. The individual will collaborate across functions and work independently to design, implement, and optimize quality system solutions that enhance product reliability and process performance.**Responsibilities and Duties**•
Support company goals, objectives, policies, and procedures to ensure alignment with quality and regulatory standards.
•
Lead and manage the entire CAPA lifecycle, including initiation, investigation, action planning, implementation, and effectiveness verification.
•
Serve as Subject Matter Expert (SME) for root cause analysis; provide guidance and training on structured problem-solving tools such as 5 Whys, Fishbone (Ishikawa), and Fault Tree Analysis to eliminate systemic issues.
•
Perform and support risk assessments (e.g., FMEA) and integrate risk management principles into CAPA activities and sustaining engineering changes.
•
Identify, prioritize, and implement proactive quality improvements to prevent recurrence of issues and enhance process robustness.
•
Collect, analyze, and trend CAPA and quality system metrics to identify patterns, drive continuous improvement, and report findings to management.
•
Communicate CAPA findings, progress, and outcomes effectively across cross-functional teams, ensuring transparency and accountability.
•
Create, revise, and review Standard Operating Procedures (SOPs) and related documentation to maintain compliance with latest regulatory standards
•
Assist with internal audits and management reviews, ensuring readiness for external inspections and regulatory audits.**Requirements**•
Bachelor’s degree in an engineering or related technical discipline or equivalent
•
Minimum of 7 years in Quality Assurance/Quality Engineering role within the Medical Device Industry
•
Proven experience with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
•
In depth knowledge of CAPA process, requirements and investigational techniques
•
Working knowledge of design controls, risk management, process validation, and statistical techniques.
•
Proficiency in root cause analysis tools such as Ishikawa (Fishbone) diagrams, Fault Tree Analysis, Contradiction Matrix, and 5 Whys.
•
Ability to collect, review, and interpret data for trend analysis and continuous improvement.
•
Self-motivated, able to work independently, and driven to achieve results with a sense of urgency.
•
Effective at dealing with change and ambiguity as business needs shift, demonstrating flexibility while ensuring compliance.
•
Strong written and verbal communication skills; comfortable presenting to small and large groups.
•
Proficient in Microsoft Office Suite with advanced skills in Excel, PowerPoint, Visio, and Word.**Salary Range:** $153,977 - $169,562(Annual Base Salary)The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.**Equal Employment Opportunity**
At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.Respecting your privacy is an essential part of the Company’s privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant’s application for employment, a Contract Worker’s work, or a Former Employee’s employment at Recor. Refer to our
for more detail information.remote type:
Onsitelocations:
Palo Altotime type:
Full timeposted on:
Posted 30+ Days Ago #J-18808-Ljbffr