Quality Engineer

Quality Engineer Location: San Diego, CA Onsite Flexibility: Onsite Contract Details Position Type: Contract Contract Duration: 6 months (extension possible) Pay Rate: $43.00–$45.00 / Hour (USD) Shift / Schedule: First shift; flexible start between 7:00 AM–9:00 AM (must be in by 9:30 AM); typical schedule 8:00 AM–4:00 PM or 9:00 AM–5:00 PM, Monday–Friday; no overtime or weekend work expected Travel Requirements: Not required Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. Job Summary The Quality Engineer II is responsible for validation of analytical methods, cleaning, production process, equipment qualification, facilities/utilities qualification, and raw materials qualification. Additionally, generate and maintain process FMEA for production processes, perform risk assessments for process related non-conformances and planned deviations, provide support and content for regulatory submissions, write master validation plans, protocols and reports, support equipment and facilities change controls, and perform validation impact assessment for change orders. Key Responsibilities Provides Quality leadership to new product development teams in the areas of validation, design transfer, risk management and specification development. Author master validation plans and reports. Author and execute validation protocols and reports (Analytical Methods, Equipment, Facilities/Utilities, Raw Materials, Process, and Cleaning). Review the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities). Determine validation strategy based on acceptable risk-based approach. Lead cross-functional team to write PFMEAs under limited supervision. Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV). Assist in maintaining validation records. Support cross-functional teams during New Product Introduction (NPI) and Sustaining projects. Review regulatory submissions and/or notifications under limited supervision. Propose improvement projects with supporting data, flowcharts, etc. Assist in developing/updating departmental procedures and other controlled documents. Evaluate adequacy of specifications for new or modified process designs under limited supervision. Lead department and cross-department projects under limited supervision. Determine QE deliverables and assist in generating project timelines. Participate in process design reviews. Assist QE management in Material Review Board (MRB) and Production Response Team (PRT) meetings. Participate in department process improvements goal(s). Assist in development, maintenance, and reporting of department metrics. Provides management with status updates on assigned responsibilities, goals and escalates issues in a timely fashion. Required Skills Proficient in validation methods and evaluation criteria. Experience with process validation, analytical method validation, cleaning validation, facility/utility and equipment qualifications. Experience with change control process and documentation requirements. Experience with electronic document management systems. Understanding of statistics, SPC and acceptance sampling. Experience with risk analysis and PFMEA. Working knowledge of CDRH, CBER and ISO regulations (e.g., 21 CFR Part 820, ISO 13485, ISO 14971). Working knowledge of 21 CFR Part 11. Authoring validation protocols, strategies, and reports. Review of change control with good GMP knowledge. Detail oriented. Proficiency in MS Word, Excel, and Project. Good problem-solving skills. Ability to work cross-functionally with other departments. Organized — able to manage multiple projects and tasks. Communication — keeping every department in the project aware of the project needs. Communication with cross-functional teams and escalation with management. Ability to work independently in a fast-paced environment. Education Requirements Bachelor's degree in Science or Engineering. Required Experience 0–2 years of experience in a diagnostic, medical device, biotech or pharmaceutical company (per job description); minimum 3 years desired per hiring manager. Experience authoring validation protocols and reports. Experience authoring risk assessments (PFMEA, NCE). Preferred background in validation experience with custom equipment, design of validation protocols, statistical sampling, and risk assessment in FMEA format. Work Environment / Physical Requirements Sit; use hands to finger, handle or feel objects, tools or controls. Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. Lifting/moving and carrying products weighing up to 40 pounds. Exposure to moving mechanical parts, vibration and/or moderate noise levels. Exposure to hazardous chemicals or other materials. Exposure to blood. Dress code: casual, closed-toe shoes required for lab. PPE required for lab support: lab coat, booties, safety glasses. Badging/access requirements: Yes. On-site parking available; no assigned parking. Benefits Medical, Vision, and Dental Insurance Plans 401k Retirement Fund #J-18808-Ljbffr