Senior Quality Specialist

1 week ago


sunnyvale, United States Kelly Science, Engineering, Technology & Telecom Full time

Title: Sr. Quality Specialist

Location: Sunnyvale, CA

Job Type: 2-year Contract, Full-Time, On-Site (M-F: 1st Shift)

Compensation: $64-$84/hour (DOE) + Kelly Standard Benefits


Job Description:

The Sr. Quality Specialist is responsible for supporting quality systems activities related to assay development, especially, design control and risk management activities in accordance with FDA and ISO regulations. This position is part of the Product Lifecyle Quality group in R&D and reports to the Sr. Manager, Product Lifecyle Quality and will be onsite based, located in Sunnyvale, California.


Responsibilities:

  • Participate as Quality representative on select product development teams which includes providing guidance for Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Risk Assessments, and Design Reviews; and provide guidance and decisions on product development activities to ensure continued compliance with internal procedures and applicable ISO and FDA standards.
  • Provide design control guidance to junior NPI Quality specialists and provide technical oversight of product shelf-life/stability program.
  • Fulfill all quality planning, stability, and risk management deliverables with feedback from cross-functional teams.
  • Ensure required documentation is completed prior to new product launch, and coach product development teams to successful completion where necessary.
  • Provide technical expertise for post market investigations and design changes, including documentation of investigations following standard out of specification SOPs and assessment of changes using design control methods.


Requirements:

  • B.S. degree with 5+ years of related experience or M.S. degree with 3+ years of related experience, degree in Chemistry, Biology, or related physical or biological science field.
  • Related work experience in Quality with a focus on assay development in a medical devices or pharmaceutical industry with applicable knowledge of cGMP, ISO, and FDA regulations.
  • Experience in implementing design control and risk management activities.
  • Experience with technical data and capable of making risk-based recommendations, taking into account broad perspectives that support both the regulations and the business.
  • Adept with Microsoft Word, Excel, Visio, PowerPoint, and Minitab.
  • Quality Systems/Quality Engineering background in molecular biology products or molecular diagnostic products utilizing PCR (preferred)



  • Sunnyvale, United States Kelly Science, Engineering, Technology & Telecom Full time

    Title: Sr. Quality SpecialistLocation: Sunnyvale, CAJob Type: 2-year Contract, Full-Time, On-Site (M-F: 1st Shift)Compensation: $64-$84/hour (DOE) + Kelly Standard Benefits Job Description:The Sr. Quality Specialist is responsible for supporting quality systems activities related to assay development, especially, design control and risk management activities...


  • sunnyvale, United States Kelly Science, Engineering, Technology & Telecom Full time

    Title: Sr. Quality SpecialistLocation: Sunnyvale, CAJob Type: 2-year Contract, Full-Time, On-Site (M-F: 1st Shift)Compensation: $64-$84/hour (DOE) + Kelly Standard Benefits Job Description:The Sr. Quality Specialist is responsible for supporting quality systems activities related to assay development, especially, design control and risk management activities...


  • Sunnyvale, United States Kelly Services Full time

    Title: Sr. Quality Specialist Location: Sunnyvale, CA Job Type: 2-year Contract, Full-Time, On-Site (M-F: 1st Shift) Compensation: $64-$84/hour (DOE) + Kelly Standard Benefits Job Description: The Sr. Quality Specialist is responsible for supporting quality systems activities related to assay development, especially, design control and risk management...


  • Sunnyvale, California, United States Sunrise Senior Living Full time

    About the Role:Sunrise Senior Living is seeking a dedicated and compassionate Caregiver to join our team. As a Caregiver, you will play a vital role in providing high-quality care and services to our residents, promoting their independence and well-being.Responsibilities:- Build meaningful relationships with our residents and their families, providing...


  • Sunnyvale, California, United States Sunrise Senior Living Full time

    About the Role:We are seeking a compassionate and dedicated Caregiver to join our team at Sunrise Senior Living. As a Caregiver, you will play a vital role in providing high-quality care and services to our residents, ensuring their physical, emotional, and social needs are met.Responsibilities:Build meaningful relationships with residents and their...


  • Sunnyvale, California, United States Sunrise Senior Living Full time

    About the Role:As a Caregiver at Sunrise Senior Living, you will have the opportunity to make a meaningful difference in the lives of our residents. Our Caregivers are responsible for providing exceptional care and support to our residents, ensuring their physical, emotional, and social needs are met. Responsibilities:- Build strong relationships with...


  • Sunnyvale, California, United States Sunrise Senior Living Full time

    Job Title: Medication AideAbout the Role:We are seeking a skilled Medication Aide to join our team at Sunrise Senior Living. As a Medication Aide, you will be responsible for the administration of medications to our residents, ensuring their safety and well-being.Key Responsibilities:Administer medications to residents as prescribed by their...


  • Sunnyvale, California, United States Amazon Full time

    Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for evaluating device functionality and creating test strategies and test cases to assess device quality for multiple regions.Key Responsibilities:Evaluate device functionality and create test...


  • Sunnyvale, California, United States Sunrise Senior Living Full time

    Job OverviewSunrise Senior Living is a leading provider of senior care services, and we're seeking a highly skilled Assisted Living Coordinator to join our team. As a key member of our leadership team, you will be responsible for facilitating and leading the Assisted Living Neighborhood team.Responsibilities Plan, organize, and develop the overall operation...


  • Sunnyvale, California, United States IntelliPro Group Inc. Full time

    Job Title: Senior Medical Billing SpecialistJob Summary: We are seeking a highly skilled Senior Medical Billing Specialist to join our team at IntelliPro Group Inc. This role will be responsible for performing complete medical billing and reimbursement functions, as well as all aspects of the medical revenue cycle for Remote Patient monitoring, Chronic care...


  • Sunnyvale, California, United States iParametrics Full time

    Electrical Quality Control SpecialistiParametrics is seeking an experienced Electrical Quality Control Specialist to join our team. As an Electrical Quality Control Specialist, you will be responsible for ensuring the quality of electrical systems in construction projects. Your expertise will be crucial in inspecting electrical installations, verifying...


  • Sunnyvale, California, United States Compass Group, North America Full time

    About the RoleThe Compass Group, North America is currently seeking an experienced Senior Cafe Operations Specialist to join our team. This role is responsible for ensuring the highest standards of food safety, quality, and customer satisfaction in our cafes. The ideal candidate will have a passion for delivering exceptional customer experiences and a strong...


  • Sunnyvale, California, United States Akraya Full time

    We are seeking a Quality Assurance Specialist for a contract position who possesses strong communication skills, an ability to tackle challenges head-on, and a propensity for meticulously testing and breaking websites. The successful candidate will play a crucial role in collaborating with Developers, Product Managers, and other Quality Engineers to...


  • Sunnyvale, California, United States EMCOR Group Full time

    Job SummaryMorley Moss, Inc., a subsidiary of EMCOR Group, Inc., is seeking a highly skilled Quality Assurance and Control Specialist to join its team. As a key member of the construction team, this individual will be responsible for ensuring that all quality control policies and procedures are followed at the jobsite.Key Responsibilities Oversee the daily...


  • Sunnyvale, California, United States Experis Full time

    Job Summary:We are seeking a highly skilled Senior Hardware Quality Assurance Engineer to join our team at Experis. As a key member of our engineering team, you will be responsible for ensuring the highest quality of our products.Key Responsibilities:Plan, write, and execute system stability tests with a focus on hardware-centric software risks.Develop and...


  • Sunnyvale, California, United States People Tech Group Inc Full time

    Job Title: Senior Engineering ManagerDescription:We are seeking a Senior Engineering Manager to lead our engineering team in Sunnyvale, California. As a Senior Engineering Manager, you will be responsible for team leadership and management, product validation strategy, test automation and infrastructure, testing and troubleshooting, and continuous...


  • Sunnyvale, California, United States People Tech Group Inc Full time

    Job Title: Senior Engineering ManagerLocation: RemoteAbout the Role:We are seeking a highly skilled Senior Engineering Manager to lead our wearable hardware validation team. As a key member of our engineering team, you will be responsible for developing and implementing comprehensive validation strategies to ensure our products meet quality, functionality,...


  • Sunnyvale, California, United States Sunrise Senior Living Full time

    Job Overview:At Sunrise Senior Living, we are committed to providing the highest quality of care and services to our residents. As a Medication Nurse LVN, you will play a vital role in ensuring the health and well-being of our residents by administering medications and treatments in a safe and organized manner.Responsibilities:Administer medications to...


  • Sunnyvale, California, United States Amazon Full time

    Job Title: Senior Cloud ArchitectAbout the Role:We are seeking a highly skilled Senior Cloud Architect to join our team at Amazon. As a Senior Cloud Architect, you will be responsible for designing and building highly scalable, cloud-native applications on the AWS platform using core developer services such as API Gateway, Lambda, SQS, DynamoDB, and ECS.Key...


  • Sunnyvale, California, United States Sunrise Senior Living Full time

    Job Title: Medication Nurse LVN PositionAbout the Role: We are seeking a skilled Medication Nurse LVN to join our team at Sunrise Senior Living. As a Medication Nurse LVN, you will be responsible for providing high-quality care to our residents by administering medications and treatments in a safe and organized manner.Responsibilities:* Administer...