The Senior Quality Analyst is part of AbbVie’s Medical Device Center (MDC) and reports into a member of MDC’s Shared Services management. The MDC is headquartered in Lake County, IL with a satellite location in Irvine, CA.
The role performs a variety of tasks related to monitoring of the Quality Management System pursuant to regulatory and statutory requirements (21 CFR 820, MDR 2017/745, EN ISO 13485). Primary responsibilities vary based on need but may include focus in any of the following areas: CAPA/NCR, Change Control, Data Analytics, Post-Market Reporting (e.g., CER, PMCF, PSUR, etc.), Quality Performance Metrics, and Trend Analysis.
Within the assigned primary focus area(s), it is expected that the Senior Quality Analyst become a Subject Matter Expert.
Duties & Responsibilities
- Design Change Control (Primary Function). Participate in departmental Change Control activities, utilizing Design Control knowledge to perform design change impact assessments.
- CAPA/NCR. Conduct, lead, or participate in investigations and review boards for CAPAs, NCRs, Observations, etc.
- Data Analytics/Trend Evaluation. Perform Trend Monitoring of post-market data, conduct in-depth analysis of anomalous findings, and escalate, as appropriate.
- Post-Market Reporting. Write and/or update Clinical Evaluation Plans, Clinical Evaluation Reports, Post-Market Clinical Follow-up Plans and Reports, and Periodic Safety Update Plans and Reports in accordance with EU MDR 2017/745 (i.e., CEP, CER, PMCF, PMSR, PSUR). This includes literature aggregation and review in conjunction with the Medical Writing team.
- Aggregate and analyze assigned Quality metrics for review by management
- Develop Quality Plans and manage projects, as assigned
- Escalate discrepancies and confirmed or potential Quality issues to management
- Present issues to larger quorums using PowerPoint
- Review and approve changes relevant to the department
- Support internal audits
- Support interactions with regulatory authorities (e.g., Notified Body audits)
- Write and revise procedures, forms, and other documents, as needed
- Work with the cross-functional team to drive change and continuous improvement
Bachelor’s degree with 6 years’ experience experience working with medical devices or medical device components (e.g., ISO 13485, ISO 9001) including experience working in CAPA or Design Control, Post-Market Reporting.
Direct experience working in CAPA, Design Control, Post-Market Reporting
Working knowledge of 21 CFR 820, EU MDR 2017/745, ISO 13485, and ISO 14971
Working knowledge of Design Control per 21 CFR 820.30
Working knowledge of CAPA Tools, including 5-Whys, Ishikawa, etc.
Working knowledge of tools/statistics used for data analysis (e.g., Pareto charts, histograms, etc.)
Strong analytical skills
Strong attention to detail
The ability to recognize problems and take corrective measures
Analytical, organized, with strong multitasking abilities
Fluent in verbal and written English
Experience with , TrackWise, Polarion, Veeva platforms, or other Quality IT systems
ASQ Certification (e.g., CQA, CQE) or equivalent
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.