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Senior Quality Analyst, Device Post-Market Reporting

Employer
AbbVie
Location
Lake County, Illinois
Start date
Nov 11, 2023

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Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

Job Details

The Senior Quality Analyst, Post-Market Reporting is part of AbbVie’s Medical Device Center within the Shared Services function (“MDCSS”).  This position’s primary focus is on Post-Market Risk, and reports to the Manager, Post-Market Device Quality (or equivalent).

The role performs a variety of tasks related to maintenance and post-market evaluation of the Quality Management System pursuant to regulatory and statutory requirements (21 CFR 820, MDR 2017/745, EN ISO 13485).  Primary responsibility is Post-Market Reporting (e.g., PMCF, PMSR, PSUR, etc.), however the role may also entail analyzing complaints, analyzing post-market signals, collecting data, and evaluating other measures of product performance (e.g., CAPA/NCR).

The Senior Quality Analyst serves as a cross-functional team advocate, tasked with assuring stakeholder concerns are addressed during planning and/or execution of assigned activities. 

Duties & Responsibilities

§   Assess trends escalated by Signal Detection, as assigned

§   Conduct investigations for CAPAs, NCRs, Observations, etc.

§   Coordinate and schedule post-market reporting activities (e.g., CERs, PMCFP/PMCFR, PMSP/PMSR/PSURs, etc.)

§   Author or update Post-Market Reporting documents (e.g., PMCFP/PMCFR, PMSP/PMSR/PSURs, PRER, etc.)

§   Work with internal business partners to ensure timely collection and assessment of relevant data (e.g., complaint trends, literature reviews, medical assessments) to drive evidence-based conclusions regarding product performance and safety

§   Escalate discrepancies and confirmed or potential Quality issues to management

§   Develop Quality Plans and manage projects, as assigned

§   Support interactions with regulatory authorities (e.g., Notified Body audits)

§   Write and revise process-related procedures, forms, and other documents, as needed


Qualifications Bachelor’s degree preferably in Engineering or Science Six years of experience within the Pharmaceutical industry, preferably regulated environment  (e.g., ISO 13485, ISO 9001)

§   Experience working with EU MDR 2017/745, 21 CFR 820

§   The ability to recognize problems and take corrective measures

§   Analytical, organized, with strong attention to detail

§   Fluent in verbal and written English

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.


Company

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Telephone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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