Job Description:
Roles and Responsibilities: EU, FDA and ROW Complaint Investigation compliance, health hazard evaluation, medical device reporting, and post market surveillance of human, oncology and prenatal next generation sequencing products. Complaint investigation of assays involves microarrays, reagents, instruments, and software. Evaluate all incoming complaints (internal or external) to determine the level of investigation required and any reporting to regulated bodies and field. Trend and evaluate systemic issues and perform root cause analysis, corrective actions and preventive action (CAPA) for complaints, as necessary. Perform health hazard evaluation and risk assessment and determine and document for any recalls, field corrections and medical device reporting. Develop effective testing parameters to understand the root cause of the complaint using input from the customer and internal SOPs. Maintain customer complaint documentation including complaint details, product return information as per the regulatory requirements. Communicate with marketing, R&D and operations personnel during the course of the investigation of customer complaints.Manage interdepartmental/global teams to investigate and correct the root cause of all verified complaints through the established CAPA system. Record complete and accurate findings regarding each complaint investigation, including the conclusion and any corrective action required. Communicate findings to technical services and management in concise summary formats. Determine the regulatory reporting requirements for each complaint and prepare the necessary reporting documentation for submission to regulatory agencies. These reports include Medical Device Reports, Vigilance Reports, Canadian Problem Reports, etc. Monitor MedWatch for any unreported claims and evaluate the need for an investigation. Track, compile, and report on complaint metrics. Qualifications:
Additional Info:
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek –– so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com. Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster available here: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf, https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please contact +1-262-754-5030 (US and Canada only) or email job_posting@agilent.com. EOE AA M/F/Vet/Disability [Click Here to Access the Original Job Post]
Roles and Responsibilities: EU, FDA and ROW Complaint Investigation compliance, health hazard evaluation, medical device reporting, and post market surveillance of human, oncology and prenatal next generation sequencing products. Complaint investigation of assays involves microarrays, reagents, instruments, and software. Evaluate all incoming complaints (internal or external) to determine the level of investigation required and any reporting to regulated bodies and field. Trend and evaluate systemic issues and perform root cause analysis, corrective actions and preventive action (CAPA) for complaints, as necessary. Perform health hazard evaluation and risk assessment and determine and document for any recalls, field corrections and medical device reporting. Develop effective testing parameters to understand the root cause of the complaint using input from the customer and internal SOPs. Maintain customer complaint documentation including complaint details, product return information as per the regulatory requirements. Communicate with marketing, R&D and operations personnel during the course of the investigation of customer complaints.Manage interdepartmental/global teams to investigate and correct the root cause of all verified complaints through the established CAPA system. Record complete and accurate findings regarding each complaint investigation, including the conclusion and any corrective action required. Communicate findings to technical services and management in concise summary formats. Determine the regulatory reporting requirements for each complaint and prepare the necessary reporting documentation for submission to regulatory agencies. These reports include Medical Device Reports, Vigilance Reports, Canadian Problem Reports, etc. Monitor MedWatch for any unreported claims and evaluate the need for an investigation. Track, compile, and report on complaint metrics. Qualifications:
- Bachelors or Master’s degree in Biological Sciences or equivalent (BioInformatics, Chemistry or Bio-Chemistry is a plus)
- 3 years of laboratory bench work experience
- Up to 5% travel may be required.
- Familiarity with ISO 13485, ISO 17025 and QSR quality management system requirements and IVD products.
- Proficient in Microarray testing, biological reagent testing, data analysis and workflow troubleshooting including instrumentation, arrays and biological materials.
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Additional Info:
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek –– so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com. Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster available here: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf, https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please contact +1-262-754-5030 (US and Canada only) or email job_posting@agilent.com. EOE AA M/F/Vet/Disability [Click Here to Access the Original Job Post]