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Quality Engineer 5924

Company: Infosoft TekSolution PVT LTD
Location: Orange
Posted on: September 15, 2022

Job Description:

One of our clients is looking for a talented and highly motivated Quality Engineer II. Please send your resume if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position.Here are the job position details for your review:Job Title: Quality Engineer IIPay Rate: $45 to 49/HrDuration: 12 MonthsLocation: Orange County, CAOur Client is a Global Medical Device Manufacturer.We are looking for a Quality Engineer IIDuties: Applies knowledge of technical principles and systems/procedures to optimize manufacturing processes.Key Responsibilities: Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations) Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes Establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.) Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work Other incidental duties assigned by Leadership Manage or assume functional responsibility for large projects or multiple smaller projects. May supervise other Engineers or manage other resources (external partners, contracts, budgets, etc) Demonstrate project ownership and accountability for project results. Develop working relationships outside of the department, cross-functionally. Think strategically as it pertains to a given project. Perform gap analysis on existing documents, assess, and revise to current QMS DHF and DMR documents requirements. This includes design, process, risk management, and other quality system documents. Work with cross-functional team (Complaints Engineering, Clinical, Product Safety Quality, R&D, Regulatory, etc) to resolve complex engineering gaps and concerns found during the remediation or . Perform other duties and responsibilities as assignedSkills: Design control, auditing, design review, process development and control, sterilization, or project management (i.e., product development team participation) Problem solving and process improvement skills a must. Effective communication and writing skills are required. Ability to work well both independently and as a member of a team is essential. Strong analytical and skills are preferred. Must be legally authorized to work in the U.S.Education: Bachelor's Degree in Engineering or Scientific field, 2 years experience Required or Master's Degree or equivalent with an internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education Required. High Level of Proficiency in medical device Quality, Regulatory or R&D experience is preferred.Job Types: Full-time, ContractSalary: $45.00 - $49.00 per hourBenefits: Dental insurance Health insuranceSchedule: 8 hour shiftCOVID-19 considerations:Vaccination is MustAbility to commute/relocate: Orange, CA: Reliably commute or planning to relocate before starting work (Required)Application Question(s): Please Prove an E-Mail IDEducation: Bachelor's (Required)Experience: Manufacturing Process: 1 year (Required) Medical Device: 1 year (Required) Risk Management: 1 year (Required) Post-Market Surveillance: 1 year (Required) Quality/Validation: 1 year (Required)Work Location: One location

Keywords: Infosoft TekSolution PVT LTD, Orange , Quality Engineer 5924, Engineering , Orange, California

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