Quality Engineer - Focus - San Juan Capistrano, CA - Monday-Friday
The Quality Engineer will have knowledge and experiencerelating to Quality processes and regulations, and will efficiently performresponsibilities in these areas with minimal supervision. He/She will guideProject teams ensuring that Design Control and product requirements are met andrepresent the Quality role during the Product Development process and DesignReviews. He/She will provide Quality perspective on DesignVerification/Validation study protocols and data analysis incorporatingrequirements or recommendations from applicable regulatory guidances andconsensus standards. The Quality Engineer will identify and improve Quality andManufacturing processes needing enhancement, provide guidance and support toManufacturing staff relating to equipment and process validations, performbatch record review and ensure that all activities are performed and documentedappropriately. Support Quality System processes e.g. Design Control, RiskManagement, CAPAs, NCPRs, Document and Change Control, and Labeling. Mentor andtrain Manufacturing and Development personnel on Quality System processes andindustry standard/best practice.
Provide technical analysis of processes that are involved inthe development of products and the manufacturing of products in order toensure that products developed and manufactured are consistent and meetspecifications. Be a knowledgeable resource in IVD product development and ISO/FDAQuality System Requirements for manufacturing and development personnel.
. JOB RESPONSIBILITIES:
• Apply Quality Tools in Root Cause Investigations, Designsof Experiments, Stability Studies, Design Verification/Validation and RiskManagement.
• Establish and maintain Design History Files, Device MasterRecords and other product related documentations in accordance with the DesignControl procedures.
• Investigate process and products failures and implementlasting solutions of such failures.
• Manage manufacturing, equipment and validation activitiesas assigned to ensure that they are well established and compliant with theregulations. Lead manufacturing and development staff in implementation ofthese processes.
• Identify and lead improvement and lean projects.
• Interface with internal stakeholders to reach consensussolutions to any issues that arise
• Participate in Audits (Internal and External), andRegulatory authority inspections and ensure that risk to company is minimizedas much as possible.
• Analyze and investigate the root cause of external andinternal nonconforming products.
• Support purchasing and receiving controls and work veryclosely with suppliers of critical components and sub systems. Participate inSupplier Audits.
• Gather, analyze, and report data reflecting status ofproduct and processes and provide recommendations to improve such activities.Analyze data from customer complaints, internal audits, internal/externalsupplier's data and implement appropriate solutions.
• Participate in Management Reviews.
• Responsible for performing assigned tasks in accordancewith applicable safety regulations and instructions, as well as correctingunsafe work habits and practices and/or bringing to the attention of the SafetyTeam or a supervisor any practice or condition that may be detrimental to thesafety and health of the employees. You also have a responsibility to cooperatein all safety or health-related programs and assist in solving safety andhealth problems. Violations of safety directives and procedures will be handledin accordance with the established Company disciplinary process.
• Perform other duties as assigned.
SUPERVISORY RESPONSIBILITIES None
• Bachelor's Degree preferred in a life sciences disciplinesuch as: Biochemistry, Chemistry, Microbiology, Biotechnology, Bio-Engineering,Molecular Biology, Animal Sciences, and Toxicology also ManufacturingEngineering, Quality Engineering and Quality Assurance.
• Two to five years related experience in IVD, medical,pharmaceutical, or other related industry.
• Must have a thorough understanding of statisticalanalysis, statistical process control, Investigation and Root Cause Analysis,Corrective and Preventive Action Process, and their application to developmentand manufacturing processes as a problem identification and resolution tool.
• Proficient in Quality Analysis Tools (Taguchi, Fishbone)& DOE.
• FDA Product and Process Validation Techniques.
• Solid experience in Assay and Consumable/Reagentsdevelopment in IVD industry.
CERTIFICATES, LICENSES, REGISTRATIONS
Lean/Six Sigma Greenbelt ASQ Certified Quality Engineer desired
OSHA RISK CATEGORY Category I - tasks which involve exposure
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