QA CAPA Engineer II

facilitation of investigations and provide input to Critical to Quality (CTQ) parameters to support overall site improvement efforts.What will you do?Provide quality support for issues requiring impact assessment, root cause analysis, identification of appropriate corrective actions, implementation of CAPA plan and monitoring of effectivenessWork directly with investigation teams on critical quality issuesFacilitate investigation activities related to process/product deviations and out of specification conditions by applying various root cause analysis (RCA) methods and tools such as Cause and Effect Diagrams, 5-Whys...etc.Implement corrective and preventative actions (CAPAs) to prevent recurrence of deviations and nonconformances. Verify effectiveness of implemented changes utilizing the proper quality tools.Perform statistical analysis to track report data to support the site (e.g. CAPA, Right First Time)Contribute to continual process improvement by participating in Kaizens, Gemba tours

and site projects.Support activities within the Quality Management System as requiredREQUIREMENTSHow will you get here?Education:Bachelor of Science (BS) from accredited college/university or equivalent experience. Preferred Science or Engineering DegreeExperience:Minimum of 2 years of relevant Quality/manufacturing/engineering experience in a regulated industryKnowledge, Skills, Abilities:Accomplished written, oral and presentational skillsMust be comfortable working as a team member (multi-functional)Have excellent interpersonal, time management, decision-making and conflict management skillsGood data analysis skills, with an ability to use statistical methods to conduct quality investigations.Comfortable in conversing at all levels within the organizationAbility to perform multiple tasksGeneral knowledge of ISO 13485 standards and/or FDA cGMP regulations (i.e 21 CFR 820).Computer skills: knowledge of Microsoft Office applications (Work, Excel and PowerPoint) is a must.

Knowledge of a statistics data software (Minitab, JMP...etc) is highly desirable. Knowledge of TrackWise CAPA Management System is a plus.Must maintain high ethical standards to support a professional business code of conductLocation: Bedford, MACompensation and BenefitsThe salary range estimated for this position based in Massachusetts is $66,000.00-$88,000.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:A choice of national medical and dental plans, and a national vision plan, including health incentive programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8
weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discountFor more information on our benefits, please visit