Quality Intern
Otsuka Pharmaceutical Co., Ltd, Palo Alto, CA, United States
At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise(TM) 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 Quality Intern will primarily support validation of Adobe Sign for 21 CFR Part 11 compliance by defining intended use and requirements, and by developing and executing validation documentation (protocol and report). In addition, the intern will help strengthen the connection between post-market quality sources and risk management by improving complaint and NCMR trending outputs and supporting their integration into risk management deliverables.**Responsibilities and Duties*** Define Adobe Sign intended use and user/compliance requirements for 21 CFR Part 11–relevant electronic records and electronic signatures (including audit trail, signer identity, signature attribution, and record retention).* Draft, execute, and document Adobe Sign validation activities (protocol, test evidence, traceability to requirements, and final validation report) to support Part 11 compliance.* Develop a thorough understanding of complaint and NCMR data sources and workflows to ensure trending outputs are accurate, traceable, and usable for risk management.* Use Excel, Power BI, and other tools to analyze and visualize complaint and NCMR data, including recurring issues, rates, and severity/impact indicators where available.* Help integrate complaint and NCMR trending outputs into risk management deliverables (e.g., risk file updates and periodic risk reviews), including documenting linkages from trends to hazard/harm evaluations and risk control effectiveness where applicable.**Requirements*** Undergraduate/ Graduate full-time student with at least 2 years in school. Pursuing a degree in Engineering or Science Degree* Proficient in Microsoft Office suite and capable of learning new software* Experience in data analysis and visualization using Excel, Power BI, JMP, R or similar software is highly valued* Must have good verbal and written communication skills* High attention to detail and organizational skills* Ability to operate independently or in a team* Interns are expected to work onsite at the Palo Alto office five days a week throughout the 12‐week internship period.**Salary range**: $20/Hr - $25/HrThe 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.**Pre-Employment Requirement**At Recor Medical, patient safety and compliance are at the heart of everything we do. To support these standards, employment for all field-based roles is contingent upon successfully completing a pre-employment background check and/or drug screen. These steps help ensure we bring the highest level of integrity and accountability to the physicians and patients we serve.**Radiation Safety Requirement**Certain field-based roles at Recor Medical require work in environments where radiation sources (e.g., x-ray equipment) are in use. Employees in these roles will be issued a personal dosimetry badge to monitor occupational exposure and are required to wear it in accordance with company policy and applicable regulatory standards. This program is designed to ensure compliance with federal and state regulations and to maintain radiation exposure at levels that are As Low As Reasonably Achievable (ALARA). Additional guidance and protective equipment, as necessary, will be provided as part of onboarding and ongoing safety training.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.
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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.**Pre-Employment Requirement**At Recor Medical, patient safety and compliance are at the heart of everything we do. To support these standards, employment for all field-based roles is contingent upon successfully completing a pre-employment background check and/or drug screen. These steps help ensure we bring the highest level of integrity and accountability to the physicians and patients we serve.**Radiation Safety Requirement**Certain field-based roles at Recor Medical require work in environments where radiation sources (e.g., x-ray equipment) are in use. Employees in these roles will be issued a personal dosimetry badge to monitor occupational exposure and are required to wear it in accordance with company policy and applicable regulatory standards. This program is designed to ensure compliance with federal and state regulations and to maintain radiation exposure at levels that are As Low As Reasonably Achievable (ALARA). Additional guidance and protective equipment, as necessary, will be provided as part of onboarding and ongoing safety training.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