Post Market Quality Specialist 2
Share
Job Location:
Newark, DE - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
The Post Market Quality Specialist performs statistical analysis of complaint and post market data for assigned Hologic product families identifying trends emerging signals and opportunities for quality improvement. The Specialist owns and leads the Post Market Surveillance Review Boards (PMS RBs) presenting product performance metrics trend summaries and identified signals requiring follow up.
Working in close partnership with Product Quality Engineers (PQEs) the Specialist supports moderate complaint investigations by providing high quality data analysis code review and early signal assessment to inform cross functional decisions. The role maintains and reconciles PMS datasets contributes complaint data for required PMS documentation and serves as the primary point of contact for complaint related analytics.
Essential Duties and Responsibilities:
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Complaint & Post Market Data Analysis
- Perform routine and ad hoc analysis of complaint and post market data for assigned product families
- Identify trends anomalies and early warning signals using statistical methods and established KPIs
- Extract and validate complaint data to support PQEs QDEs and cross functional investigation teams.
- Conduct as reported vs. as analyzed complaint code reconciliation to ensure accurate surveillance insights.
PMS Review Boards (PMSRBs)
- Own schedule prepare and present BU level Post Market Surveillance Review Boards
- Summarize key complaint trends signals KPIs and actions required for follow up
- Ensure PMS RB records are accurately documented and released in PLM in a timely manner
Investigation Support
- Support product investigations in partnership with PQEs and QDEs providing data analysis trending support and preliminary signal assessment.
- Provide rapid complaint data inputs for emerging issues field escalations and early investigations
- Perform queries and generate trend analyses for CAPA inputs Health Risk Assessments (HRAs) and cross functional assessments
PMS Documentation & Reporting
- Supply complaint data for PMS Plans PMS Reports PSURs and Canadian Summary Reports as requested
- Provide complaint data to support PMCF and Clinical Evaluation documentation
- Maintain surveillance trackers templates and other PMS documentation tools to ensure accuracy consistency and compliance
- Compile and report weekly and monthly surveillance metrics and KPIs to support Quality leadership
Cross Functional Collaboration
- Partner closely with PQEs Product Support QDEs and other key functions to ensure consistent complaint coding accurate data interpretation and alignment on findings
- Support cross functional discussions on product performance emerging risks and needed follow up actions
Continuous Improvement & Data Quality
- Recommend and implement improvements to complaint coding data quality PMS processes and analytical workflows.
- Support alignment of divisional PMS processes with corporate standards and data governance expectations.
- Contribute to internal and external audits/inspections by providing accurate complaint data and documentation support.
Qualifications:
Education
- Bachelors degree in Engineering Science or related technical field
Experience
- 3 years in post market quality complaint handling quality engineering or similar analytical role. Medical device experience preferred
Skills
- Strong analytical and statistical skills; experience identifying trends and early warning signals
- Working knowledge of FDA 21 CFR 820.198 ISO 13485 ISO 14971 and EU MDR PMS requirements
- Strong communication skills for presenting data to cross functional teams and leadership
- Effective organization prioritization and problem solving skills
- Computer skills: Microsoft Office Minitab Oracle Agile and Salesforce (H1)
Why Hologic
We are committed to making Hologic the company where top talent comes to grow. For you to succeed we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
If you have the right skills and experience apply today!
#LI- AV1
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Required Experience:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
Hologic is a global champion of women’s health. We integrate The Science of Sure into everything we do to help improve and save lives through early detection and proactive treatment.
