Validation/CQV Engineer

DUTIES AND RESPONSIBILITIES: Collaborate with Engineering and Quality on equipment / process changes, additions and installs for how to qualify equipment, processes and newly developed coatings Preparing and reviewing validation protocols, engineering study reports, results from trials and test work, parameter development and operational qualifications, including challenge tests to establish and demonstrate stable processes and capability. Collaborate with document control to approve and release into QMS. Perform basic to intermediate statistics for the analysis of data Update, where necessary, the Validation Master Plan with outcomes of executed qualifications / validations Lead and support process time studies, value stream and process mapping, and capacity analysis Support development of user, functional, and equipment requirement for new and existing equipment Work within the established company-wide quality documentation system and QMS, including key aspects such as executing and supporting test methods per procedure, collecting and documenting test results, writing test data reports and procedures Follow Quality Management System requirements in an ISO 13485 / GMP manufacturing environment Performs other related duties as assigned by management

QUALIFICATIONS: Minimum of 7yrs experience in engineering or equivalent and an engineering bachelor’s degree Medical device and/or medical component experience is a must Can interpret schematics, engineering drawings, written and verbal instructions Understands the operation and functionality of process equipment; conducts tests and reports data in prescribed format Experience in planning, preparing and executing validations protocols and reports, writing and implementing procedures, development of processing parameters, executing and documenting trials, IQ/OQ/PQ, navigating quality management systems Strong computer and communication skills. Fluent in English, both written and spoken Self-motivated. Able to work effectively both within a team and independently Proven experience supporting complex problem solving using systematic and critical thinking skills Seniority levelSeniority level Associate Employment typeEmployment type Contract Job functionIndustries Medical Equipment Manufacturing Referrals increase your chances of interviewing at IntePros by 2x Inferred from the description for this jobMedical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Validation Engineer” roles. QA Specialist II, Validation, ContractorFranklin, MA $95,000.00-$110,000.00 1 week ago Massachusetts, United States $65.00-$70.00 1 week ago Boston, MA $102,100.00-$111,700.00 2 weeks ago Marlborough, MA $75,000.00-$80,000.00 5 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.