Job Details

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.Position DescriptionCollaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role.As a Quality Engineer I, you will learn and develop skills to support medical device quality through investigation of non-conformances, root cause analysis, risk assessment, and implementation of corrective and preventive actions as part of a cross-functional team.Key ResponsibilitiesPerform oversight and approval of Corrective and Preventative Actions (CAPA)Conduct experiments to prove hypothesesImplement statistical techniques to determine sample sizes and levels of confidenceImplement statistical process controls to monitor validated processesWork with process owners to design engineering test protocols and use a data-driven approach to collect, analyze and summarize data into engineering reportsPerform root cause investigations for design and manufacturingGenerate protocols and reports for Installation, Operational and Performance Qualification (IQ, OQ, PQ)Collaborate with design and manufacturing teams to assess device risk profileand failure modes in design (dFMEA)and manufacturing (pFMEA)Success in This Role Looks LikeExhibiting a strong technical understanding of the product lines and projectsPerforming in-depth, comprehensive investigationsDeveloping interpersonal connections and relationships with others to effectively accomplish project objectives and deliverablesLeading moderate to high-risk investigations with minimal guidance or directionDemonstrating a strong understanding of Applied's Quality Management System (QMS) and effectively troubleshoot challenges or obstacles that may affect project timelinesPosition RequirementsThis position requires the following skills and attributes:Bachelor's degree in an Engineering or Science, Technology, Engineering, and Mathematics (STEM) field or related education and experienceEffective oral and written communication skillsExcellent problem solving/critical thinkingAbility to work effectively in cross-functional teamsWorking knowledge of Microsoft Office, including Word, Excel, and OutlookDATA ANALYSISThe job requires conducting thorough investigations and analyses to identify the underlying causes of problems or failures and develop effective solutions to prevent their recurrence.CRITICAL THINKINGThis role will require the ability to comprehend and think critically about a multitude of varying processes throughout the company. Being able to objectively analyze a situation and make a reasonable judgement is essential.COMPREHENSIVE KNOWLEDGEThe job necessitates a solid understanding of root cause analysis, hypothesis testing, and problem solving to perform investigations and provide objective evidence of issues present.PreferredThe following skills and attributes are preferred:Experience in ETQ Reliance or equivalent electronic Quality Management softwareProcess improvement or project management experienceWorking knowledge of statistics as it relates to quality metrics and confidence intervals.Understanding of manufacturing, quality and risk managementstandardsBenefitsCompetitive compensation range: $72000 - $78000 / year (California).Comprehensive benefits package.Training and mentorship opportunities.On-campus wellness activities.Education reimbursement program.401(k) program with discretionary employer match.Generous vacation accrual and paid holiday schedule.Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.All compensation and benefits are subject to plan documents and written agreements.Equal Opportunity EmployerApplied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.#J-18808-Ljbffr