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Quality Engineer

Company: ProArch Consulting Services
Location: Fremont
Posted on: May 3, 2021

Job Description:

We are a leading manufacturer and supplier of flow cytometry products and services. Our compact, affordable instruments and wide-ranging support offerings are used by researchers and clinicians all over the world. Job Location: Fremont, CAMAJOR DUTIES AND RESPONSIBILITIES: The Quality Engineer will support Manufacturing, Supply Chain, and Customer Facing functions on applicable product quality, design control, and risk management processes. Conduct investigation and analysis of failed system modules, create analysis reports and provide recommendations for continuous quality improvement.Support test method development and evaluate test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives. Generate or apply statistical methods with appropriate risk-based justification. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and verified. Promote continuous improvement in design control activities and use of quality tools. Define critical to quality characteristics and inspection plans for components, subassemblies, and finished devices. Identify and propose remediation for existing and potential quality issues.Ensure that product changes to existing products are conducted in compliance with Regulatory and Quality standards. Maintain expertise in both current and emerging requirements and quality trends as they relate to life science products and medical devices worldwide. Provide Risk Management support to all quality subsystems. EDUCATION REQUIREMENTS: Minimum of a BS in Engineering or Scientific discipline; MS preferred EXPERIENCE QUALIFICATIONS: Experience in Biotech instrument development and commercialization activities. Experience with product risk analysis and management throughout the product lifecycle. Experience with injection molding and assembly preferred.Familiar with reliability analysis and test methods and test method validation. Familiar with process validation principles, including subtasks of equipment IQ, OQ, PQ. Working knowledge of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, and ISO 14971 Risk Management Standard. tools for managing quality performance CQE preferred Education4+ years experience working in the Medical Device and/or Life Science Research product industries. Experience interacting with regulatory agencies and notified bodies and front room audit experience is a plus. Knowledge and experience with corrective action and preventive action systems, release test statistical sampling methods, quality risk management, FMEA, and DOE. OTHER QUALIFICATIONS: Experience using the Windows OS, MSOffice Applications, Engineering Change Order Systems, Device History Records, and the creation of Procedures and Reports. KEY SKILLS AND COMPETENCIES: Strong verbal (including presentation) and written communication skills, especially technical report writing. Demonstrated knowledge of QMS, GMP, ISO9001, and UL standards. Knowledgeable in manufacturing techniques and processes. Problem-solving, analytical, creativity, and critical thinking skills. Ability to effectively influence others without direct authority and partner with internal and external customers. PHYSICAL REQUIREMENTS: Individuals will be required to be able to work in a standing position for an hour at a time. Associated topics: bio, bioengineering, bioinformatic, biophysics, metabolic, msat, neurodegenerative, parenteral, pathogenesis, therapeutic

Keywords: ProArch Consulting Services, Fremont , Quality Engineer, Other , Fremont, California

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