Risk Management / Post Market Surveillance Analyst II
• Facilitates cross-functional PMS/ Risk activities/local and long distance meetings
• Analysis of product performance by reviewing quality data (such as complaint rates) and determining trends related to company and competitor products.
• Leads local and long distance PMS / Risk activities/meetings and tracks open items to ensure timely issue closure.
• Ensures Analyses of PMS data by performing or coordinating with appropriate local and long distance groups.
• Supports Regulatory Affairs for various regulatory submissions and inquiries from Notified Bodies and governmental agencies including alignment of PMS and Risk activities associated with Risk Benefit and Clinical Evaluation Report activities.
• Leads activities related to risk planning, risk assessments and risk management reports including reporting of risk activities to site Quality leadership during management reviews.
• Ensures compliance to PMS schedules and creates / maintains metric reports on the PMS system for review
• Works with local and long distance product teams to develop/ maintain PMS requirements
• Develops and provides training on PMS / Risk requirements.
• Works with various local and long distance departments to identify and analyze trends arising from quality data (i.e. complaints, nonconformances, clinical studies, competitive products, and manufacturing changes).
• Leads Nonconformance / CAPA initiatives related to Risk / Post Market Surveillance.
• Bachelor degree in Engineering, Science or related field with 2-4 years work experience preferably in a regulated field environment OR equivalent job related experience of 6-8 years med device PMS/Risk Management experience in lieu of degree
- Extensive experience with Microsoft Office applications including Word, Excel, Access, PowerPoint, Project and Outlook including charting and pivot tables.
• Strong experience with Statistics, sample size determination and familiarity with Mini Tab or similar statistical software a plus.
Preferred Position Requirements
Extensive experience with Microsoft Office applications including Word, Excel, Access, PowerPoint, Project and Outlook including charting and pivot tables.
In addition to the basic qualifications listed above, the following other position requirements are recommended:
• Experience with regulated medical environments such as medical devices, pharma, or food and drug, including GMPs and Medical Device Directive
• Experience with analyses of product development and manufacturing engineering including risk management
• Experience with analyses of data such as product complaints, clinical studies, and competitive products for further analysis
• Experience with International Organization for Standardization (ISO) standards
• Experience in creating, reviewing, and approving quality systems documentation.
• Experience establishing statistical sampling requirements related to component/process critical and application of risk management
• Experience with statistical software and statistical sampling
• Experience with project management
• Demonstrated presentation and communication skills
• Demonstrated ability to condense complex requirements into specific and measurable objectives
• Demonstrated understanding of the application of Corrective and Preventive Action.
• Ability to deal effectively with employees and external business contacts while conveying a positive, service-oriented attitude
• Ability to work independently and as part of a team
In addition to the basic qualifications and other position requirements listed above, the following preferred qualifications are recommended:
• American Society for Quality (ASQ) Certified Quality Engineer
• Knowledge of FDA and MDD requirements concerning medical devices
• Medical device manufacturing experience
• Six Sigma Certification
• Experience with Notified Bodies and ISO 13485, 14971The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor