Job Description:
Job Duties:
Serve as the quality representative for new product introduction and new product improvement projects for all product types; participate in team meetings and coordinate quality activities as required Assist with the verification and validation experimental design; coordinate with regulatory affairs and R&D to confirm experimental design conforms to appropriate regulatory requirements Create and/or update design and process FMEA Review, create, and/or update traceability matrices Conduct detailed reviews of all design history files; coordinate with project management, R&D, and manufacturing as needed ensure the project deliverables are complete, accurate, and in compliance with regulatory requirements Coordinate efforts associated with the preparation of regulatory documents or submissions in a timely manner to facilitate worldwide product launches Assess and update design and quality process documentation as required to elevate existing Research Use Only (RUO) products to Class I Clinical Laboratory Instruments, Software, General Purpose Reagents and/or CE-IVD regulations Identify gaps and update Design History Folders (DHF) and Device Master Records (DMR) for the existing products Identify gaps in design verification and validation and update them to meet the requirements of Class I and/or II medical devices Create and/or update technical files As needed, coordinate with production manufacturing to bring device master record documentation to QSR levels Qualifications:
Qualifications:
Bachelors or Master's Degree or equivalent in Biological science or equivalent combination of education and experience Prior experience in a biological manufacturing environment. Must have prior experience with wet lab bench work. Prior experience with next generation sequencing is preferred Experience writing and executing validation protocols and reports for the medical device industry or complimentary industry Experience in ISO13485 or other quality environment supporting clinical markets Understanding of how to work quickly in a regulated environment establishing processes for integration of revision control, validation, and implementation of changes Experience with bioinformatics and statistical design is greatly preferred Proficient in Microsoft office suite required. Experience using bioinformatics data analysis software is preferred Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
Company:
Agilent
Additional Info:
[Click Here to Access the Original Job Post]
Job Duties:
Serve as the quality representative for new product introduction and new product improvement projects for all product types; participate in team meetings and coordinate quality activities as required Assist with the verification and validation experimental design; coordinate with regulatory affairs and R&D to confirm experimental design conforms to appropriate regulatory requirements Create and/or update design and process FMEA Review, create, and/or update traceability matrices Conduct detailed reviews of all design history files; coordinate with project management, R&D, and manufacturing as needed ensure the project deliverables are complete, accurate, and in compliance with regulatory requirements Coordinate efforts associated with the preparation of regulatory documents or submissions in a timely manner to facilitate worldwide product launches Assess and update design and quality process documentation as required to elevate existing Research Use Only (RUO) products to Class I Clinical Laboratory Instruments, Software, General Purpose Reagents and/or CE-IVD regulations Identify gaps and update Design History Folders (DHF) and Device Master Records (DMR) for the existing products Identify gaps in design verification and validation and update them to meet the requirements of Class I and/or II medical devices Create and/or update technical files As needed, coordinate with production manufacturing to bring device master record documentation to QSR levels Qualifications:
Qualifications:
Bachelors or Master's Degree or equivalent in Biological science or equivalent combination of education and experience Prior experience in a biological manufacturing environment. Must have prior experience with wet lab bench work. Prior experience with next generation sequencing is preferred Experience writing and executing validation protocols and reports for the medical device industry or complimentary industry Experience in ISO13485 or other quality environment supporting clinical markets Understanding of how to work quickly in a regulated environment establishing processes for integration of revision control, validation, and implementation of changes Experience with bioinformatics and statistical design is greatly preferred Proficient in Microsoft office suite required. Experience using bioinformatics data analysis software is preferred Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
Company:
Agilent
Requeriments :
- M.Sc. or higher Degree in Bioinformatics
- M.Sc. or higher Degree in Computer Science
- Master's Degree in Engineering
Skills :
Areas :
Additional Info:
[Click Here to Access the Original Job Post]