Quality Assurance Coordinator

3 weeks ago


San Juan Capistrano, United States SF Staffing Solutions Full time

DESCRIPTIONProvide technical analysis of processes that are involved in the development of products and the manufacturing of products in order to ensure that products developed and manufactured are consistent and meets specifications. Help and support such activities why ensuring that applicable standards and procedures are followed. Mentor and train junior level Quality Engineers.Participate in Project teams and representing Quality/Regulatory groups and ensuring that Design Control requirements are met. Support Corrective and Preventive actions and ensure that Root Cause Investigations are performed using appropriate Quality Tools. Support Manufacturing processes and ensure that validation activities are well documented and performed.RESPONSIBILITIES•Ensure that appropriate procedures are established to support Design Development and the Manufacturing processes.•Review of design and development processes and ensuring that appropriate documentations are established during this process and in accordance with the Design Control procedures.•Review manufacturing and validation activities to ensure that they are well established and compliant with the regulations.•Establish purchasing controls and work very closely with suppliers of critical components and sub systems.•Review specifications, operation instructions, sheets, process procedures, test procedures, inspection and test analysis.•Provide leadership in the application of Quality Tools such as Risk Management, Root Cause Investigations, Designs of Experiments, Capability Studies, in the establishment and investigation of process and products failures and implement lasting solutions of such failures.•Develop process flow diagrams and perform gap analyses on current controls versus required controls.•Establish methods to analyze and investigate the root cause of external and internal non-conforming products.•Assist in corrective and preventive actions and verifications of effectiveness checks.•Analyze data from customer complaints, internal audits, and internal and external suppliers non-conformance and implement appropriate solutions.•Develop inspection procedures and apply statistical technics and appropriate sample plans.•Gather, analyze, and report data reflecting status of product and process and provide recommendations to improve such activities.•Participate in improvement and lean projects.•Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.•Participate in Audits (Internal and External), and Regulatory authority inspections and ensure that risk to company is minimized as much as possible. Skills & Requirements REQUIREMENTS•Strong Validation/Design Control experience is highly preferred. Experience in molecular is highly preferred.•Bachelor's Degree preferred in an Engineering discipline such as Mechanical, Electrical Industrial or Manufacturing Engineering.•Three to Five years related experience in IVD, medical, pharmaceutical, or other related industry.•Must have a thorough understanding of statistical analysis, statistical process control, Investigation and Root Cause Analysis, Corrective and Preventive Action Process, and their application to development and 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 Systems Development including Hardware (Instrumentation), Software and Consumable/Reagents as applicable in IVD Industries.



  • San Antonio, United States Globus Medical Full time

    About Us:At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators...


  • San Antonio, United States Globus Medical Full time

    About Us: At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and...


  • San Antonio, Texas, United States Worldwide Clinical Trials - USA Full time

    Who we are We're a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a...


  • San Antonio, United States ResCare Full time

    Our Company ResCare Community Living Overview The Quality Assurance Manager (QAM) position is focused on maintaining local compliance with State, Federal and BrightSpring Health requirements. The QAM provides leadership oversight to operations in meeting their goals and ensure safety and satisfaction for individuals supported. Responsibilities Maintains...


  • San Juan Capistrano, United States Marriott International Inc Full time

    Job Number 24074478Job Category Sales & MarketingLocation Inn at the Mission San Juan Capistrano Autograph Collection, 31692 El Camino Real, San Juan Capistrano, California, United States VIEW ON MAPSchedule Full-TimeLocated Remotely? NRelocation? NPosition Type Non-Management POSITION SUMMARY Perform general office duties to support Sales & Marketing (e.g.,...


  • San Juan Capistrano, United States Inn at the Mission San Juan Capistrano, Autograph Collection Full time

    Job Number 24074478Job Category Sales & MarketingLocation Inn at the Mission San Juan Capistrano Autograph Collection, 31692 El Camino Real, San Juan Capistrano, California, United States VIEW ON MAPSchedule Full-TimeLocated Remotely? NRelocation? NPosition Type Non-ManagementPosition SummaryPerform general office duties to support Sales & Marketing (e.g.,...


  • San Juan Capistrano, California, United States Inn at the Mission San Juan Capistrano, Autograph Collection Full time

    Job Number Job Category Sales & MarketingLocation Inn at the Mission San Juan Capistrano Autograph Collection, 31692 El Camino Real, San Juan Capistrano, California, United States VIEW ON MAPSchedule Full-TimeLocated Remotely? NRelocation? NPosition Type Non-ManagementPosition SummaryPerform general office duties to support Sales & Marketing (e.g., filing,...


  • San Juan Capistrano, United States Marriott International Inc Full time

    Job Number 24074478 Job Category Sales & Marketing Location Inn at the Mission San Juan Capistrano Autograph Collection, 31692 El Camino Real, San Juan Capistrano, California, United States VIEW ON MAP Schedule Full-Time Located Remotely? N Relocation? N Position Type Non-Management POSITION SUMMARY Perform general office duties to support Sales & Marketing...


  • San Juan Capistrano, United States Homewatch CareGivers of Yorba Linda Full time

    Job DescriptionJob DescriptionBenefits:Legal plan401(k)Bonus based on performanceCompetitive salaryDental insuranceOpportunity for advancementPaid time offTraining & developmentVision insuranceWellness resourcesCompany partiesEmployee discountsFlexible scheduleSales and Marketing Coordinator in the Home Care IndustryHomewatch CareGivers of Yorba Linda and...


  • San Lorenzo, California, United States tapwage Full time

    Ethicon, a member of the Johnson & Johnson Family of Companies, is recruiting for a Quality Assurance Specialist located in its manufacturing site at San Lorenzo, Puerto Rico.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where...

  • Quality Engineer

    7 days ago


    San Diego, United States Cannon Quality Full time

    PURPOSE OF JOB : 2nd-level engineering role at CQG. Primarily responsible for client facing engineering solution development and implementation, and to support day-to-day activities surrounding the operation of the client(s) quality system, supplier QA, design assurance and manufacturing QA throughout the product life cycle. The QE will also provide support...


  • San Jose, United States High-Tech Professionals Full time

    Quality Assurance Engineer Job ID: 1807 Location: San Jose, CA Type: Permanent Status: Closed Key Skills: Quality Assurance, QA, EE, ME, Engineering, manufacturing, ISO, EHS, IQC, OQC, ISO 9001, audit, EHS, goverment regulations, semiconductor Description: Seeking Quality Assurance Engineer to perform the following: - Work with EE/ME design engineers to...


  • San Juan Capistrano, United States Homewatch CareGivers of Yorba Linda Full time

    Benefits: Legal plan 401(k) Bonus based on performance Competitive salary Dental insurance Opportunity for advancement Paid time off Training & development Vision insurance Wellness resources Homewatch CareGivers of Yorba Linda is currently in a growth mode and looking to hire an experienced Field Sales and Marketing Coordinator to support our territories...


  • San Juan Capistrano, United States Homewatch CareGivers of Yorba Linda Full time

    Benefits: Legal plan 401(k) Bonus based on performance Competitive salary Dental insurance Opportunity for advancement Paid time off Training & development Vision insurance Wellness resources Homewatch CareGivers of Yorba Linda is currently in a growth mode and looking to hire an experienced Field Sales and Marketing Coordinator to support our territories...


  • San Jose, United States iXsystems Full time

    Job Description Job Description Salary: $80,000 to $95,000 USD Annually iXsystems is looking for a Supervisor, Quality Assurance to join our Quality team! This position will report to the Director of Quality. As a supervisor at iXsystems, you will be instrumental in upholding the quality standards of our products and services. If you’re enthusiastic about...


  • San Luis Obispo, United States Bobit Business Media Full time

    Edge Autonomy is a leader in providing innovative autonomous systems, advanced optics, and resilient energy solutions to the US Department of Defense, the US Federal Civilian Agencies, allied governments, academic institutions, and commercial entities. We are a company built from pioneers and we believe that innovation, no matter how small or how early,...


  • San Diego, United States Medix Full time

    Organization & Job Summary Our client is a nonclinical CRO working with both small and large animal models. We work extensively in the neurologic disorder, cardiovascular, and medical device spaces. However, our culture is one of agility and places customer service at the forefront. Therefore, we work collaboratively with groups that span the breadth of...


  • San Mateo, United States Actalent Full time

    Description: Ensures site quality oversight of commercial and/or development products at CMOs. Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality subfunctions. Partners with Development, Manufacturing, Supply Chain, Outsourcing and Drug Substance to deliver on...


  • San Jose, United States iXSystems Full time

    Job DescriptionJob DescriptionSalary: $80,000 to $95,000 USD AnnuallyiXsystems is looking for a Supervisor, Quality Assurance to join our Quality team! This position will report to the Director of Quality.  As a supervisor at iXsystems, you will be instrumental in upholding the quality standards of our products and services. If you’re enthusiastic about...


  • San Diego, United States VALID8 Financial Full time

    Gamma Scientific, located in San Diego offers the world’s most comprehensive selection of precision light measurement instruments, backed by the industry’s most knowledgeable support team. We have an opening for the following position in our QA department. Essential Job duties of the Quality Assurance Supervisor: Manages all quality activities within...