div>About The Job
Location: Milpitas, CA [Onsite]
Employment Type: Full-time, Non-Exempt
Department: Quality
Reports To: Quality Manager
.
USI/Asteelflash is actively seeking a dedicated Quality Specialist to join our team here in Milpitas, CA.
Pleasanton, CA25 days ago
li>Decision making that has an extended impact on work processes and outcomes, that could cause substantial expenditure of additional time, human resources, and funds and jeopardize future business activity. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Pleasanton, California19 days ago
Foster City, CA30+ days ago
Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering.
Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance.
Alameda, California20 days ago
Excellent verbal and written communication skills Competencies Identified for Success: Passionate About Problem -Solving: As a results -oriented self -starter, you are eager to leverage your expertise in identifying inefficiencies, analyzing root causes, and recommending effective solutions. This position is responsible for supporting product release and key Quality Management System (QMS) processes, including deviations, nonconformances (NCM), CAPA, complaints, and change control, for the Plain City, Ohio , US, manufacturing site and the Redcar, UK, site.
p>The Quality System Specialist is responsible for developing, implementing, maintaining, and continually improving the organization's management systems, including Quality (ISO 9001/IATF 16949/AS9100/ISO 13485), Environmental (ISO 14001), Occupational Health & Safety (ISO 45001), and Information Security (ISO 27001). Founded in 1991, weve grown into a leading provider of electronics manufacturing services (EMS), offering a comprehensive suite of solutions from design and manufacturing to supply chain management.
Foster City, CA30+ days ago
p>The Training Specialist supports Product Development and Manufacturing (PDM) and Quality organizations by assessing training impact, designing risk-based and compliant training solutions, and optimizing training curricula aligned to job roles and Quality System expectations. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
South San Francisco, CA30+ days ago
In this on-site contracted role, you will lead the enhancement and maintenance of local Quality Systems, with a primary focus on the Quality Management System (QMS), Electronic Data Management System (EDMS), Document Control, and overall Quality Assurance functions. This role is integral to the overall GxP Quality system, including processes such as Change Control, Deviation, CAPA, Training, and Document Control, as well as tracking and reporting Quality System Metrics.
Pleasanton, CA30+ days ago
Reporting to the Head of Quality and Regulatory, the Quality Assurance Manager will play a pivotal role in defining, developing and implementing the lab's quality infrastructure, ensuring compliance with CLIA, CAP, and state (including California and New York) requirements. • Clinical Quality Framework Establishment and Oversight Implement document control, deviation/CAPA systems, training programs, and internal audit processes compliant with CLIA, CAP, and applicable state and federal regulations.
Cupertino, CA30+ days ago
p>Develop and implement scalable QA protocols - including sampling strategies, inter-annotator agreement measures, and error taxonomy frameworks - to ensure consistent, high-quality labeled data. As Senior Manager of QA for Data Annotation, you will own the end-to-end quality assurance strategy for annotation pipelines that feed directly into Apple's AI and machine learning models.
Alameda, California6 days ago
San Jose, California30+ days ago
Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the world’s first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.
$200,000 - $250,000 a year
. The team works collaboratively to ensure compliance with the quality system while meeting business objectives.
More about our benefits
Visby offers highly competitive health insurance through United Healthcare or Kaiser, including a company-funded HSA option.
Support vigilance and medical device reporting activities, including Advisory Notices, Field Safety Notices (FSN), Field Safety Corrective Action (FSCA) working with Regulatory Affairs. She/he is responsible for performing quality assurance related functions independently including but not limited to maintaining the quality system in accordance with ISO 13485.
Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Lead, oversee or contribute to multiple portions of the Quality System, including but not limited to Design controls, software development, risk management, Product changes, product Release, NC/CAPA, and others as needed.
style="min-height:1.5em">Active, unrestricted licensure as an Advanced Practice Provider (Nurse Practitioner, Physician Assistant, Clinical Nurse Specialist, or equivalent) and willingness to obtain additional state licensure upon hire. Establish and monitor key performance indicators (KPIs) including pain and symptom management outcomes, patient/family satisfaction (e.g., CAHPS), avoidable hospitalizations, goals-of-care documentation rates, and advance directive completion.
Cross functional team lead that independently handles complex, multi-faceted deviations, investigations, OOS, CAPAs and change controls that impact multiple departments including (but not limited to) manufacturing, E&T and supply chain. + Expert in analytical methods, execute critical decision making, work independently with very little supervision, champions problem resolution, knows when to escalate to upper management, and provides compliant and smart solutions for complex validation issues.