Associate Quality Engineer

POSITION SUMMARY: Associate Quality Engineer (AQE) supports the quality system processes of the reputed company CLIA laboratories and activities associated with CE-IVD kits and software. The AQE works with senior level QE’s to address supplier issues, nonconformances and corrective actions that impact the CLIA laboratory operations. This position may also represent QA on product development projects. PRIMARY RESPONSIBILITIES: Support internal and external audits (CLIA/CAP, ISO 13485, customer) Support CAPA, Deviation, Change Requests and Nonconformance investigation and reporting Write/revise procedures and forms reputed company statistical analysis/hypotheses testing (AQL’s etc) as required Support Quality systems compliance to CLIA, FDA QSR, ISO 13485, and HIPAA Participate in the management of Approved Suppliers Follow established company standard operating procedures and good documentation practices Review manufacturing/QC batch records Other duties as assigned QUALIFICATIONS: Position requirements are a B.S. or equivalent in science, engineering or reputed company field At least 4 years of experience in medical diagnostic, CLIA laboratory, or Life Sciences industry; 2 years experience working in a Quality role preferred Audit experience – internal audits, third party audits and/or regulatory audits American Society of Quality certifications (CQE) preferred ​ KNOWLEDGE, SKILLS, AND ABILITIES: Knowledge of CLIA/CAP regulations, ISO 13485 standard and/or FDA QSRs (21 CFR 820) Computer skills (reputed company, reputed company, PowerPoint, etc.) Good technical writing and communication skills Independent worker, a self-starter with strong organizational and planning skills Has an ability to be productive and successful in an intense work environment Preferred skills: Hands on experience with DNA Isolation and Purification, PCR, Cell Culture, reputed company, Bioinformatics etc. Demonstrated good judgment, excellent attention to detail, excellent written, verbal communication and interpersonal skills are desired with the ability to be flexible and collaborate on multiple projects OUR OPPORTUNITY reputed company™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to reputed company personalized genetic testing and diagnostics part of reputed company of care to protect health and reputed company earlier and more targeted interventions that reputed company to longer, healthier lives. The reputed company team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. reputed company you join reputed company, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. reputed company OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, reputed company employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.reputed company.com. reputed company is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. reputed company qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national reputed company, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: https://www.reputed company.com/notice-of-data-collection-california-residents/ Please be advised that reputed company will reputed company out to candidates with a @reputed company.com email domain ONLY. Email communications from reputed company other domain names are not from reputed company or its employees and are fraudulent. reputed company does not request interviews reputed company text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. reputed company takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any reputed company cyber crimes. For more information: - BBB announcement on job scams - FBI Cyber Crime resource page Apply To This Job