Principal Product Surveillance Analyst
Endologix – Irvine, CA
OverviewEndologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.Perform the preliminary classification of complaints and elevate complaints that require reporting for additional review.Evaluate documentation for completeness and consistency, and execute additional actions as necessary to close the complaint file.Recognize complaint trends, potential product problems and potential recalls, and initiate immediate remedial action, if appropriate.Identify and elevate new failure modes when encountered.Maintain oversight of the Complaint Handling daily processes to ensure issues are being addressed in a timely and compliant manner.Communicate with Clinicians, Clinical Education, Sales and Marketing teams, and other internal or external customers, to identify details related to complaint information and occurrence.Perform Good Faith Effort for product return and to obtain required information for complaint assessment and evaluation.When necessary, perform investigation of returned devices.Work with engineering groups to ensure testing as required on product investigations is completed.Prepare responses to customer requests for failure analysis as necessary.Proactive individual with ability to communicate and work well with others.Actively collaborate with cross-functional key stakeholders (Commercial Organization, Design & Development, Risk Management, Manufacturing, Supply Chain, Reliability, Pre-Market Quality/Regulatory, Clinical/Medical, and Marketing) in support of post market surveillance plan and report creation to assess the safety, effectiveness and performance of our regulated products/devicesResponsible for obtaining data from multiple sources including but not limited to Complaints, Adverse Events, Recalls, Risk Management, CAPAs, Non-conformances, Validations, Literature) and perform the required analysis in applicable data analysis tools (Excel, Minitab, Access or similar applications); utilize public databases for obtaining post market data on competing products for comparative analysis. Responsible for ensuring traceability, reproducibility and consistency of the results generatedResponsible for reviewing data analysis with the PMS Manager to detect emerging trends of such issues that may require action and escalation to Senior Leadership and BU partners. Work closely with PMS Manager to continually seek to identify new feeder systems to effectively monitor product performance after launchResponsible for compiling data and preparing reports at periodic intervals as required by regulationsSupport PMS Manager to partner with product functional areas to ensure that PMS output is fed back into R&D, Design Quality, Supplier Quality, CAPA Board and Marketing where applicable to achieve a closed-loop processMaintain professional and technical knowledge and continually update knowledge on competing product technologies in the Market by reviewing publicationsMaintain current knowledge of global regulations impacting PMS. Apply knowledge to develop and optimize processes, and suggest improvement to current processes as neededQualificationsBachelors degree or equivalent experience in Quality or Regulatory.Minimum of 8 years of medical device experience (Class II/III) or a combination of clinical and medical device experiencePrior experience with post market surveillanceComprehensive knowledge of quality systems and relationship to business.Be able to identify missing information, evaluate accuracy of the presented informationDemonstrates strong attention to detail.Must demonstrate technical writing ability.Good interpersonal skills including ability to interact with high degree of diplomacy.Ability to work in a fast-paced, technically challenging environment where drive is critical to success.Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.Effective problem solving techniques and excellent applied thinking skills.Strong communication and organization skills required.Expertise in Microsoft Office applications and charting programs.
The Principal Post Market Surveillance Analyst is responsible for performing domestic and international product surveillance activities for medical devices, manufactured, marketed, distributed and serviced by Endologix. Primary responsibility for all administrative activities associated with the complaint handling program including, but not limited to, reviewing, managing and closing complaints records in the complaint handling system. Principal Post Market Surveillance Analyst will prepare failure analysis responses for customers and close complaints. Position may also be responsible for some regulatory reporting.Responsibilities
Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, gender expression, genetic information, marital status, veteran status or any other characteristic protected by applicable federal, state, or local law.
If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800.
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