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Terumo BCT Global Quality Risk Manager in Lakewood, Colorado

Requisition ID: 27360At Terumo Blood and Cell Technologies, our 7,000+ global associatesproud to come to work each day, knowing that what we do impacts the lives ofpatients around the world.We make medical devices and related products that are used to collect,separate, manufacture and process various components of blood and cells.With our innovative technologies and service offerings, we touch apatient's life every second of every day and are committed to continuing toincrease the number of patients we serve.With some of the best and brightest minds in the industry, an unmatchedglobal footprint, comprehensive benefits and a distinct culture, TerumoBlood and Cell Technologies is a great place to work, grow and be part of ateam that is focused on making a difference. Consider joining our team andunlock your potential.The Quality Risk Manager will develop and oversee Quality Management Systemrelated activities for Risk Management and ensure alignment and integrationwith the company's quality system procedures and processes. The Manager willplay an integral role in designing and implementing quality risk managementprocesses that are leveraged throughout the product life cycle and areleveraged cross-functionally throughout the organization.ESSENTIAL DUTIESResponsible for the development and maintenance of Global Risk Managementquality procedures and applicable quality plans in compliance with ISO13485, ISO 14971, EU MDR, CMDR, and FDA Quality System RegulationsDevelops and implements effective training programs related to Risk Managementand Post Market Surveillance to achieve and maintain quality system andregulation awareness, ISO certifications and Quality System compliance.Works with global QMS process owners to develop and implement risk-basedstrategy across the companyWorks closely with medical safety contributors to maintain the company'sMaster Harms listConsults with Terumo Corporate on Risk Management best practicesEnsures alignment of product hazard analysis for consistent decision makingand actions across all functional areas and post-market activitiesCollaborates with clinical affairs, quality and regulatory compliancedepartments to ensure appropriate monitoring and feedback through post marketdata.Researches, sets and reports appropriate metrics to monitor the health ofRisk Management procedures and processes.Pursues the proactive development of new and existing business processintegration of Risk Management beyond product quality management.Manages and provides leadership for the functional group's development,direction, and effectiveness, adhering to organizational policies andprocesses and supporting overall business and corporate objectives.Responsible for the project and or work group expenditures vs. plan.Implements and understands FDA or regulatory requirements as necessary.Ensures compliance with Quality System regulations and safe working practices.Plans, guides, and reviews projects and or work groups under one'scontrol to produce the desired outcome.Utilizes technical skills to evaluate proposed solutions, adaptations, andmodifications to projects.MINIMUM QUALIFICATION REQUIREMENTSEducationBachelor's degree or equivalent of education and experience sufficient tosuccessfully perform the essential functions of the job may be considered.Bachelor of Science or Master of Science Degree in Engineering, preferred.ExperienceMinimum 10 years experience.SkillsExpert knowledge in Risk Management and Post Market Surveillance regulatoryrequirements.Proven ability to solve practical problems in a collaborative manner whichyields effective compliance with QMS and external standards while allowing forthe use of efficient and flexible implementation approaches.Possesses a strong drive to seek and solve existing or latent problems.Maintains a consistent and resolute willingness to take ownership and acceptresponsibility for risk management and post market processes.Demonstrated skills in technical innovation, technical leader