CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families.We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO).CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians.More information can be found at .Test and thoroughly evaluate clinically applied medical devices and IVF products of various degrees of complexity to determine root cause analysis within a closely monitored time frame.Identifying the appropriate test method/regiment/tools from existing Standard Operating Procedures for complaint sample evaluation, execute the method, and interpret the data (technical) for definitive root cause analysis determination.Test methods may include dimensional and/or tensile testing and interpretation of the technical data yielded in accordance with USP/EP/ASTM standards.Evaluate and review repair logs and field service reports to determine root cause of alleged complaint conditions.Replicate reported failure mode with bench top simulation test methods and document observations accordingly with returned product or similar product as necessary.Collaborate with the Quality Engineering and R&D groups on investigation activities as required and driven by complaint investigation outcomes.Prepare technical investigation reports based on results of evaluation and/or review of the service and repair activities and/or investigation of the alleged product failure.Responsible for providing detailed investigation results for customer letters.Participates in weekly team investigation reviews, investigation status meetings, and displays team problem solving/communication skills.Review and close complaint files after reviewing for accuracy, compliance to Departmental Standard Operating Procedures, and Regulatory compliance/audit readiness.Certification with OSHA's BloodBorne Pathogens Standard 29 CFR 1910.1030.Perform additional duties or assignments as required by management Bachelor's Degree in Engineering or Science required +1 year of relevant experience.Critical Independent Thinking, Time Management, and timely follow up.Ability to work independently and in a team setting.Quality or compliance experience is preferred with familiarity with root cause investigation tools and techniques.Excellent interpersonal, organization, and project management skills with the ability to prioritize job functions with attention to detail.Ability to analyze and process data and draw the appropriate conclusions.Excellent verbal, written, and presentation skills in English with an emphasis on technical writing.Strong operating knowledge of MS Office suite (Outlook, Word, & Excel).Working knowledge of Master Control and/or IQVIA preferred.We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status.We are proud to be an equal opportunity workplace.
