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Quality Assurance Technician
1 week ago
Petit Pot Emeryville, United StatesAbout Petit Pot · In 2014, while trying to find the perfect dessert to go with dinner, French pastry chef Maxime realized something was missing in his local grocery store: Pot de crème As a fan of all things sweet, Maxime decided to address this craving by founding Petit Pot in S ...
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Quality Assurance
3 weeks ago
University of California San Francisco San Francisco, United StatesThe Quality Assurance (QA) Manager will oversee the activity of the quality assurance department and staff, developing, implementing, and maintaining a system of quality and reliability testing for the organization's products and/or development processes. QA deliverables and mana ...
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Quality Assurance Technician I
3 weeks ago
Rotisystems Oakland, United StatesGeneral Description · This position is responsible for the inspection and testing of manufacturing processes and products to ensure the product safety and quality. Daily tasks include routine quality checks, QA inspection, record keeping, CCPs monitoring, equipment calibration, a ...
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Quality Assurance Coordinator
3 days ago
Teksky Inc Emeryville, United States**JOB: Quality Assurance Coordinator** · **Location: Emeryville, CA** · **Employment Type: On-site Full-time.** · **Position Summary**: · The Compliance Coordinator is responsible to ensure that all production paperwork is completed, collected, organized, reviewed, and filed to t ...
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Quality Assurance Manager
2 weeks ago
Bayview Hunters Point Foundation for Community Imp San Francisco, United States**What We Do**: · Bayview Hunters Point Foundation has been at the heart of social justice for over 50 years, providing support services for predominantly low-income people of color in the Bayview and throughout San Francisco. · Our mission is to build a community that is empower ...
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SCS Global Services Emeryville, United States**Company Overview** · **Job Overview** · **Essential Duties and Responsibilities** · - Assist in maintaining the integrity of working documents and updating documentation when revised · - Assist in maintaining the document control system · - Ensure all documentation assigned for ...
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Manager, Quality Assurance
3 weeks ago
Cutera Brisbane, United States**Company Description** · We're Growing - With Growth Comes Opportunity · **Job Description** Position Summary**: · The individual is responsible for activities that lead to, and maintain compliance to/with Cutera's Quality Management System and maintains regulatory approval to m ...
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Quality Assurance Manager
3 weeks ago
Actalent San Mateo, United States Full timeDescription: · • Ensures site quality oversight of commercial and/or development products at CMO's. · • Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality subfunctions. · • Partners ...
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Quality Assurance Specialist
2 weeks ago
Actalent San Mateo, United States Full timeDescription: · Role and Responsibilities: · • Review and approve master batch records, labels, specifications and other pre-production documents for Clinical/Commercial Drug Product in compliance with FDA and international health agency requirements. · • Review executed productio ...
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Quality Assurance Manager
3 weeks ago
Actalent San Mateo, United States Full timeDescription: · • Ensures site quality oversight of commercial and/or development products at CMO's. · • Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality sub functions. · • Partners ...
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Quality Assurance Specialist
3 weeks ago
Actalent San Mateo, United States Full timeQuality Assurance Specialist · HYBRID role, onsite in Foster City, CA · Description: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilanc ...
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Quality Assurance Tech I
3 weeks ago
Intelliswift Software, Inc. San Francisco, United StatesPay rate range - $40/hr. to $42/hr. on W2 · ** Must Have** · Able to run test cases without running into issues · able to find bugs/ resolve bugs · Able to follow a release checklist/identify task · Requirement · - Also looking to have very hands-on knowledge of QA processes: · W ...
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Quality Assurance Specialist
2 weeks ago
Actalent San Mateo, United States Full timeDescription: · 20% BRR · 80% Analytical focused · • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements · • Serves as QA Lead for clinical and commercial projects. · • Leads quality investigations/deviations/ ...
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Director, Quality Assurance
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Cellares South San Francisco, United StatesWe are seeking a highly motivated collaborative Director of Quality Assurance for our South San Francisco location to develop, establish, implement and maintain a phase appropriate cGMP Quality management system for the Cell & Gene Therapy operations to support pre-clinical and c ...
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · • Receives product quality complaints (typically via phone or fax or email), from healthcare professionals and patients · • Documents all incoming complaints in to complaint management system timely and notifies other QA specialists for start of investigations · • ...
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Quality Assurance Specialist
3 weeks ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaint from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to the Pharmacovigilance Department. Performs or provides support for product complaint investigations · ...
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Quality Assurance Specialist
2 weeks ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilance Department. Performs or provides support for product complaint investi ...
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Quality Assurance Specialist
3 weeks ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilance Department. · Performs or provides support for product complaint inve ...
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Quality Assurance Specialist
3 weeks ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for Gilead products from the US and Canadian markets.Documents in Gilead Quality System for investigation for product complaints and triages safety events to Gilead Pharmacovigilance Department. Performs or provides support for product ...
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Quality Assurance Employee
3 weeks ago
Nexus Dynamics Alamo, United StatesWe are a leading and internationally oriented fashion company for women's and men's trousers based near Regensburg in Europe. To strengthen our team, we are looking for: · QUALITY ASSURANCE EMPLOYEE (M/F/D) · APCT1_EN · ...
Senior Specialist Quality Assurance - Alameda, United States - Abbott Laboratories company
Description
Abbott is a global healthcare leader that helps people live more fully at all stages of life.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.
Our 114,000 colleagues serve people in more than 160 countries.About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.
You'll also have access to:
Career development with an international company where you can grow the career you dream of.
Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity This position works out of our Alameda, CA location in the Abbott Diabetes Care Division, where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions.
We're revolutionizing the way people monitor their glucose levels with our new sensing technology.The Senior Specialist Quality Assurance participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products that ensures digital applications and firmware produced by ADC is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements.
This person will monitor design controls that govern the development, verification, validation, use, and maintenance of medical device software. The Senior Specialist Quality Assurance will also coordinate activities with other engineering disciplines, departments, and contractors.What you'll work onReviews change plans for impact to project deliverables, and provides guidance to the document owners regarding changes to software requirements specifications, labeling content, and software design descriptions for Abbott's suite of diabetes management software (cloud and mobile).Reviews test plans and test reports to ensure all software changes are verified, and software system is adequately regressed across all environments in accordance with design controls and Quality System Requirements.
Monitors implementation of defect management process and provides guidance to Systems and V&V teams to ensure software bugs are logged, investigated, tested and dispositioned.
Active participant in an Agile software development process, including daily Scrum and other recurring Sprint ceremonies.Completes software quality tasks in accordance with current Quality System Requirements.
Works independently with objectives given by SWQA Manager.
Can plan and coordinate own work according to higher-level project schedules. Including direction of contract personnel to ensure projects come to fruition in a timely manner.
Assists in the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of medical device software.
Software Quality lead in various phases of the development lifecycle, as well as initiation of corrective and/or preventative action as it applies software development activities.
Maintains schedule and drive to meet project schedule as aligned with project(s) goals.Will also estimate, plan, schedule and review own and others' work products and be accountable for the quality of those reviews and delivery on schedule.
Considered SWQA compliance SME in support of external/internal audits.Required QualificationsBachelor's degree, or equivalent experience, in a scientific, technical, or engineering discipline.5 to 8 years' experience in Software Quality Assurance and/or Software Testing experience.
Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements.Must have - 4 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices and mobile applications.
Preferred QualificationsMust have excellent oral and written communication skills.ASQ Certifications a plus.
Medical Device experience strongly preferred.
Cyber security, medical mobile applications or cloud computing experience preferred.
What We OfferAt Abbott, you can have a good job that can grow into a great career.
We offer:
Training and career development, with onboarding programs for new employees and tuitionassistance Financial securitythrough competitive compensation, incentives and retirement plans Health care and well-being programsincluding medical, dental, vision, wellness and occupational health programsPaid time off 401(k)retirement savings with a generous company matchThe stability of a companywith a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.
Connect with us , on Facebook on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $95,500.00 – $190, In specific locations, the pay range may vary from the range posted.
