Senior Quality Engineer

Duration: 12+ MonthsLocation: CO-Englewood, Hybrid 1-2 days onsiteOverview: Every Turnberry consultant belongs to a practice, an internal group of consultants and leaders with shared experience and expertise. Each of these practices aligns to one of the core services Turnberry offers to clients. As a Senior Quality Engineer, you will join Turnberry's Digital Modernization practice, where technology and strategy combine to deliver exceptional digital experiences, empowering organizations to thrive in today's digital market.ResponsibilitiesReview, remediate, and migrate legacy CAPA records into EtQ to ensure completeness, accuracy, and compliance with global proceduresManage assigned CAPAs through initiation, investigation support, action tracking, effectiveness verification, and closurePerform gap assessments of CAPA records and support correction of documentation deficiencies to meet regulatory and internal quality system requirementsPartner cross-functionally with Quality, Regulatory, Operations, and Engineering to support CAPA execution and remediation activitiesSupport compliance to global CAPA procedures, including documentation standards, timeliness expectations, and record retention requirementsAssist with training and user guidance related to CAPA procedures and EtQ processesQualificationsWorking knowledge of CAPA processes, root cause analysis, and quality system requirementsExperience with electronic Quality Management Systems (EtQ preferred)Knowledge of applicable regulations and standards, including 21 CFR Part 820, ISO 13485, and risk-based quality principlesStrong technical writing and documentation review skillsStrong organizational skills with high attention to detail and ability to manage multiple prioritiesAnalytical/problem-solving skills with ability to identify gaps and drive resolutionAbility to work cross-functionally and communicate effectively across levels of the organizationProficiency with Microsoft Office (Excel, Word, PowerPoint) and document control systemsMedical device or other regulated industry experience preferredEducation And CertificationsB.S. in Engineering or an alternative Bachelor’s degree program3-5 years of experience required in a Quality Engineering role, preferably supporting CAPA processesKnowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 14971 preferredKnowledge of design controls, risk management, FMEA, CAPA, root cause investigation and statistical analysisCertified Quality Engineer (CQE) and medical device, particularly Orthopedic industry, experience preferredThe salary range for this role is $65,000 to $95,000 or the hourly equivalent. Pay is based on several factors including but not limited to education, work experience, certifications, etc. In addition to your salary, Turnberry Solutions offers benefits such as a comprehensive healthcare package (medical, dental, vision), disability and group term life insurance, health and flexible spending accounts, a utilization bonus, 401(k) with match, flexible time off for salaried employees, parental leave for salaried employees, and flexible work arrangements (all benefits are subject to eligibility requirements). No matter where or when you begin a career with Turnberry, you'll find a far-reaching choice of benefits and incentives.At Turnberry, we are committed to creating a positive and connected work environment for all and are fully invested in and focused on hiring and growing a diverse team of high performers. We believe that uniqueness in ideas, experiences, and backgrounds make us a better Turnberry: Turnberry is an Equal Employment Opportunity employer, and recruits, employs, trains, compensates, and promotes regardless of age, ancestry, family medical or genetic information, gender identity and expression, marital, military, or veteran status; national and ethnic origin; physical or mental disability; political affiliation; pregnancy; race; religion; sex; sexual orientation; and any other protected characteristics.Americans With Disabilities Act (ADA)Turnberry will provide reasonable accommodation with our application process upon request as required to comply with applicable laws. If you have a disability and require accommodation assistance in this application process, please send an email to our Human Resources department at turnberryhr@turnberrysolutions.com.