Otsuka Pharmaceutical Co., Ltd
Staff Supplier Quality Engineer
Otsuka Pharmaceutical Co., Ltd, Palo Alto, California, United States, 94306
Staff Supplier Quality Engineer page is loaded## Staff Supplier Quality Engineerremote type:
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Palo Altotime type:
Full timeposted on:
Posted 2 Days Agojob requisition id:
R10264At 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.**Job Summary**The Staff Supplier Quality Engineer ensures that all products and services provided by suppliers meet internal and external quality standards. This role involves leading supplier audits, managing quality metrics, and driving continuous improvement initiatives across the supply base. The engineer acts as a key liaison between suppliers and internal teams, ensuring compliance with regulatory requirements and company standards.**Key Responsibilities****Supplier Management & Auditing*** Lead and conduct supplier audits (ISO, GMP, FDA, etc.) based on annual schedules.* Evaluate and approve suppliers for inclusion in the Approved Supplier List (ASL).* Monitor supplier performance using KPIs.* Develop and implement supplier certification and re-certification programs.**Quality Systems & Compliance*** Ensure supplier compliance with ISO 13485, 21 CFR 820, and other applicable regulations.* Maintain and improve Supplier Quality Management metrics and documentation.* Support CAPA investigations and non-conformance resolution related to supplier issues.* Facilitate Manufacturing Quality Agreements (MQAs) and ensure proper documentation.**Product Development & Validation*** Collaborate with R&D and manufacturing teams during design and process validation phases.* Provide input on statistical methods, test methodologies, and validation protocols.* Support process improvement initiatives and risk assessments using tools like FMEA and DOE.**Training & Mentorship*** Train internal teams and suppliers on quality tools and regulatory requirements.* Mentor junior engineers and support their development in supplier quality practices.**Post-Market Surveillance*** Investigate supplier-related complaints, MDRs, and recalls.* Coordinate corrective actions and ensure timely closure of audit findings.**Qualifications****Education*** Bachelor’s or master’s degree in engineering, Life Sciences, or related technical field.**Experience*** 5–8+ years in Supplier Quality Engineering, preferably in medical devices or regulated industries.* Lead auditor experience with ISO 13485 and FDA QSRs.* Experience with CAPA, process validation, and statistical analysis.**Certifications (Preferred)*** ASQ CQE/CQA* ISO 13485 Lead Auditor* Six Sigma Green/Black Belt**Skills*** Strong analytical and problem-solving abilities.* Excellent communication and negotiation skills.* Proficiency in quality tools (FMEA, MSA, SPC) and software (MS Office, QMS platforms).* Ability to travel up to 30% for supplier audits and assessments.Salary Range: $153,977.00- - $169,562.00The 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. #J-18808-Ljbffr
Onsitelocations:
Palo Altotime type:
Full timeposted on:
Posted 2 Days Agojob requisition id:
R10264At 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.**Job Summary**The Staff Supplier Quality Engineer ensures that all products and services provided by suppliers meet internal and external quality standards. This role involves leading supplier audits, managing quality metrics, and driving continuous improvement initiatives across the supply base. The engineer acts as a key liaison between suppliers and internal teams, ensuring compliance with regulatory requirements and company standards.**Key Responsibilities****Supplier Management & Auditing*** Lead and conduct supplier audits (ISO, GMP, FDA, etc.) based on annual schedules.* Evaluate and approve suppliers for inclusion in the Approved Supplier List (ASL).* Monitor supplier performance using KPIs.* Develop and implement supplier certification and re-certification programs.**Quality Systems & Compliance*** Ensure supplier compliance with ISO 13485, 21 CFR 820, and other applicable regulations.* Maintain and improve Supplier Quality Management metrics and documentation.* Support CAPA investigations and non-conformance resolution related to supplier issues.* Facilitate Manufacturing Quality Agreements (MQAs) and ensure proper documentation.**Product Development & Validation*** Collaborate with R&D and manufacturing teams during design and process validation phases.* Provide input on statistical methods, test methodologies, and validation protocols.* Support process improvement initiatives and risk assessments using tools like FMEA and DOE.**Training & Mentorship*** Train internal teams and suppliers on quality tools and regulatory requirements.* Mentor junior engineers and support their development in supplier quality practices.**Post-Market Surveillance*** Investigate supplier-related complaints, MDRs, and recalls.* Coordinate corrective actions and ensure timely closure of audit findings.**Qualifications****Education*** Bachelor’s or master’s degree in engineering, Life Sciences, or related technical field.**Experience*** 5–8+ years in Supplier Quality Engineering, preferably in medical devices or regulated industries.* Lead auditor experience with ISO 13485 and FDA QSRs.* Experience with CAPA, process validation, and statistical analysis.**Certifications (Preferred)*** ASQ CQE/CQA* ISO 13485 Lead Auditor* Six Sigma Green/Black Belt**Skills*** Strong analytical and problem-solving abilities.* Excellent communication and negotiation skills.* Proficiency in quality tools (FMEA, MSA, SPC) and software (MS Office, QMS platforms).* Ability to travel up to 30% for supplier audits and assessments.Salary Range: $153,977.00- - $169,562.00The 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. #J-18808-Ljbffr