Quality Engineer (Medical Devices)

2 days ago Be among the first 25 applicants TalentBurst, an Inc 5000 company provided pay range This range is provided by TalentBurst, an Inc 5000 company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $35.00/hr - $42.00/hr Position: Quality Engineer I , Req#: 4979-1 Duration: 12+ Months Contract Working Hours/Location : Due to site expansion, specifically looking for candidates who have flexibility in their working hours to move into mid-shift hours , 01:00 PM – 09:00 PM . Prior to this, associates will work normal business hours through a training period before transitioning into a mid-shift schedule. Job Description: The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaints and manufacturing investigations, and representing Quality in cross-functional projects. Education and Experience: 0-3 years of relevant experience in a regulated industry (FDA environment preferred) Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard Job Responsibilities: Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance. Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks. Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization Proficient in project management, data analysis, root cause analysis, communication, and risk determination Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices. Seniority level Seniority level Mid-Senior level Employment type Employment type Contract Job function Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research Referrals increase your chances of interviewing at TalentBurst, an Inc 5000 company by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Quality Engineer” roles. Hacienda Heights, CA $68,310.00-$85,000.00 3 months ago Sr. Supplier Quality Engineer - FSD Irvine Sr Engineer, Quality Engineering (Transfers) Manufacturing Engineer in Irvine, CA (Onsite)–___Contract Only Senior Quality Engineer, Fluid Systems Division CA Quality Engineer - DOD/Aerospace, MRB, FAI, CAPA Irvine, CA $90,000.00-$115,000.00 1 week ago Principal Quality Engineer - Neurovascular - Irvine, CA or Mounds View, MN Supplier Quality Engineer, Thermal (Contract) Long Beach, CA $135,000.00-$170,000.00 2 weeks ago Santa Fe Springs, CA $72,000.00-$117,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr TalentBurst, Inc