Post Market Surveillance Specialist

Job Description

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 is currently seeking a Specialist to join the Post Market Surveillance (PMS) team in the Diagnostics and Genomics Group (DGG). Within DGG, we serve our customers who are deeply involved in improving human health. Whether it is to fight cancer or to improve the quality of life for those with a genetic disorder, patients are benefiting from the trusted answers our products deliver. Every day in this role, you are making a difference in someone’s life. 

This role drives the global post-market surveillance process within the DGG division. The successful candidate will take responsibility for executing the existing process and work with cross-functional teams to drive efficiency.

Key Responsibilities:

• Ensure collection and analysis of data required to comply with the PMS requirements of ISO13485, IVDR, ISO14971, and other geographic-specific regulations
• Writing relevant PMS reports, updating current procedures to comply with changing regulations and standards
• Present PMS report results and drive decisions based on the PMS reports
• Perform statistical analyses and develop graphs and tables for publication and presentation
• Plan and execute projects to automate data collection and analysis using new and existing software tools
• Interface with internal stakeholders to determine the optimal methodology for the collection and analysis of PMS data
• Create and maintain dashboards for tracking the status of PMS data collection and analysis across the organization
• Stakeholder management through gathering expert evaluations, facilitating stakeholder meetings, and preparing data summaries for discussion.
• Search of external data sources for relevant product information from External Quality Assessments (EQA) data, competitor adverse events and recalls, and scientific literature
• Act as subject matter expert during internal audits and external inspections.
• Prepare training in relevant areas for data collection, analysis, or more.
• Drives continuous improvement in quality management systems

Qualifications

• Bachelor's or Master’s degree in a Quantitative/Scientific/Technical discipline.
• 4+ years of work experience in the medical device or pharmaceutical industry.
• Candidates must have experience working with In Vitro Diagnostic and/or Medical Devices in roles such as lab technician, researcher, quality assurance, or working within a regulated industry.
• Strong knowledge and understanding of standards and regulations: ISO 14971:2019, Regulation (EU) 2017/746, ISO 13485, and regulations covered under MDSAP.
• Thorough understanding of statistical methods and tools: Excel, Database, Click sense, Spotfire.
• Experience with Product Life Cycle Systems is a plus!
• Proficiency in programming languages is a high desire.
• Continuous Improvement experience or LEAN mindset, is a plus.
• Substantial experience with MS Office.
• Ability to operate effectively in a team environment and independently with little direction.
• Strong verbal and written communication skills.
• Results-oriented and willing to take accountability.
• Thrive by working cross-functionally with people at all levels of the organization.
• Flexible, systematic, and engaged team player.
• Self-motivated with a high level of engagement. Positive ‘can do’ attitude.
• High proficiency in both written and spoken English.

The US pay range for this full-time position is $87,600.00 - $143,719.00/yr, plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position across the relevant US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Additional details are available at: https://careers.agilent.com/locations/americas/united-states/

Applications for this job will be accepted until at least September 3, 2024, or until the job is no longer posted.

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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.

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 email [email protected] or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Pay Range$87,600.00-$143,719.00

The salary range for this position may differ based on your actual work location.

Eligible for Company Car

No

Benefits in Brief

Option to Work RemoteYes

Travel RequiredOccasional

ScheduleSchedule:Full time

ShiftDay

DurationNo End Date

Job FunctionQuality/Regulatory