Quality Assurance Officers
Unigen
Unigen is a global technology company providing innovative electronics manufacturing and product solutions to customers across diverse industries. With decades of industry experience and operations in key global markets, we combine engineering expertise, advanced manufacturing capabilities, and responsive customer service to deliver reliable, high-quality solutions—from product development through production and fulfillment.
Unigen offers a competitive compensation and benefits package, including medical, dental, and vision coverage; paid holidays; Job Title: Quality System Specialist
Job Function: Quality Department
Report to: Senior Quality Assurance Engineering Manager
Job Summary: 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). This role ensures compliance with applicable standards, legal requirements, and customer expectations, and drives a culture of continuous improvement across all management systems.
Develop, implement, and maintain QMS, EMS, OHSMS, and ISMS in alignment with business objectives, ISO standards, regulatory requirements, and customer expectations.
Monitor changes in standards, regulations, and customer requirements, and update systems and processes as needed.
Ensure ongoing compliance with legal, regulatory, and customer-specific requirements.
Work with relevant departments to establish quality objectives and Key Process Indicators (KPIs), monitor progress toward achievement, and drive continuous improvement initiatives.
Support effective risk assessment, hazard assessment, environmental emergency, health and safety emergency testing, and contingency testing as required by applicable management systems.
Respond to customer questionnaires and surveys related to applicable management systems.
Training & Awareness
Collaborate with relevant departments on competence training programs.
Promote a culture of quality, safety, environmental stewardship, and information security. Participate in cross-functional teams to drive process improvements and risk reduction in the organization’s management systems.
Analyze data and trends to identify opportunities for improvement.
Support root cause analysis and problem-solving activities.
Associate's degree in related field.
- 2+ years of experience in management systems related to manufacturing company.
- Western & Southern Financial Group in Fremont, CA seeks an Agency Quality Assurance Analyst to test system updates across Agency Portal, VUE, Licensing Portal, Salesforce, OnBase and IVR. You will help develop business and test requirements, create test cases and perform...Suggested
$24 - $33 per hour
Job Summary The Quality Specialist executes the end-to-end Patrol Audit system and accountability programs across manufacturing facilities. This role ensures that active shopfloor processes, workstation setups, and operator adherence strictly align with the ISO 9001 Quality...SuggestedHourly payFull timeLocal areaImmediate start- ...eligible for Visa Sponsorship. Position Overview As a Senior Quality Specialist at Nestlé Nutrition & Health, your mission is to ensure quality... ...verification: Promote compliance with the Nestle Management System requirements and other applicable Standards. Member of the...Suggested
PowerToFly
Fremont, CA3 days ago $27 - $30 per hour
...promptly and professionally to customer inquiries related to quality issues, providing accurate information and resolution support.... ...Conditions – may work in hot/cold temperatures Summary The Quality Specialist I is an entry-level position focused on supporting Quality...SuggestedWork at officeMonday to FridayTheuniversityunion
Fremont, CA5 days ago$89.3k - $146.9k
...activities to provide confidence that requirements for quality and quality improvement are being met. The Quality Assurance Specialist recommends revisions to, or creation of, new protocols, policies, procedures and/or systems as a result of analysis. Understands concepts of...SuggestedFull timeTemporary workWork experience placementInternshipWork at officeWorldwideFlexible hours$95k - $110k
...Description: Position Summary: This role is part of the Quality Assurance Compliance team. As a member of the QA team, the role... ...potential suppliers through thorough reviews of their quality systems, manufacturing processes, and capabilities to ensure they meet...Work at officeAsahi Kasei
Fremont, CA4 days ago- Bionova Scientific LLC in Fremont, CA, is seeking a Quality Assurance Specialist to join the QA Compliance team. The role focuses on supplier qualification, GMP compliance, and client/regulatory audits. Strong communication and data analysis are essential as you interact...
- ...Flexibility: Hybrid or OnsiteStryker is hiring a Senior Staff Clinical Quality Associate for our Neurovascular division. This is an onsite... ...research activities. You will provide oversight of quality systems, compliance programs, audits, inspections, and clinical processes...Full timeFor contractors
$90k - $105k
...Quality Control Analyst II, Analytical ( Newark, CA) Revance Therapeutics, Inc. JOB DESCRIPTION: Perform routine and non-routine... ...to drug substance and drug products. # Microsoft Office, LIMS system, and data trending. # Data Integrity principles. TO...Contract workInternshipWork at officeRemote workRevance
Newark, CA1 day ago$105k - $129k
...within our company and in the lives of patients we serve. The Quality Assurance Specialist III, Analytical is responsible for the review and approval... ...the effectiveness and compliance of Ardelyx's Quality System. A strong background in small molecule analytical...Full timeContract workWork at officeFlexible hours2 days per week3 days per week- Responsibilities Review and approve analytical quality documentation supporting regulatory submissions (INDs, NDAs, amendments, supplements... ...specification changes impacting submissions. Review Quality System records (deviations/OOS/OOT, lab investigations, CAPAs, change...Contract workFlexible hours
- Bionova Scientific LLC in Fremont, CA is seeking a Senior QA Specialist, Supplier Quality to join the Quality Assurance Compliance team. The role... ...hybrid office/lab setting. You will assess supplier quality systems, manage change controls and investigations, and lead on-...Work at office
- Bionova Scientific LLC, a биologics CDMO, seeks a Sr. QA Specialist in Fremont, CA for supplier quality oversight. The role includes reviewing supplier quality systems, conducting on-site audits, and managing supplier documentation and quality agreements. The position...
- Bionova Scientific LLC, Fremont, CA, is seeking a Sr. QA Specialist, Supplier Quality to join the Quality Assurance Compliance team. You will assess supplier quality systems, manage supplier qualification, support self-inspections, and coordinate client and health authority...Work at office
$29 - $32 per hour
...USI/Asteelflash is actively seeking a dedicated Quality Speciali st to join our team here in Milpitas, CA. The Quality Specialist is responsible for leading and overseeing all quality inspection and assurance activities within the PCBA and Box Build manufacturing operations...Hourly payFull timeWork at officeUSI Holdings Corporation
Milpitas, CA2 days ago- Quanta Manufacturing Fremont seeks a Quality Specialist to oversee the end-to-end Patrol Audit system and ensure shopfloor processes align with ISO 9001 QMS. You will coordinate with Production Operations, Training, and Corporate QA to monitor compliance, identify drift...Full time
$105k - $125k
Revance is seeking a Sr. Specialist, Quality Assurance in Newark, CA for hands-on QA within Quality Systems, focusing on lifecycle management of GxP facilities, instruments, and computerized systems, with collaboration across Quality Control, Manufacturing, IT, Supply...Work at office- Overview Agency Quality Assurance Analyst is responsible for testing of the system updates and upgrades, including the Agency Portal, VUE, Licensing Portal, Salesforce, OnBase, and IVR. Assisting in developing business requirements, test cases and performing UAT for new...Work experience placementWork at office
- ...based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing,... ...people who have worked in IT. Required Knowledge: 4-6 years in Quality Assurance working within software industry; Knowledge of QA testing...Work experience placement
- SoundThinking is seeking a detail-oriented Collection Specialist to rigorously test the performance of our systems. This role requires travel up to 90% and hands-on data collection at customer locations. Hybrid workplace with onsite expectations for locations including...
$120k - $150k
...Program, ensuring document control processes, governance, and systems remain compliant, efficient and aligned with regulatory requirements... ...improvement projects.Monitor, analyze, and communicate key quality metrics and KPIs related to document lifecycle management and process...Full timeWork at officeLocal area$85k - $105k
...Quality Assurance Specialist Menlo Park MyOme's mission is to provide clinically actionable genetic information to patients throughout their... ...records within a QMS or electronic document management system (eQMS/EDMS). Strong organizational skills and attention...Work at officeMyOme
Menlo Park, CA3 days ago- ...Quality Assurance Specialist /Auditor LeanTeq is best-in-class in a very niche part of the semiconductor industry and is looking for quality-... ...and audits is required. Support of our Quality Management System and related documentation is also required. Essential Duties...Work at officeNight shift
EnPro
Milpitas, CA2 days ago $41.47 - $62.21 per hour
...to make rapid treatment decisions. Position Summary The Quality Assurance Associate is an enthusiastic, self-motivated person... ...Responsibilities Supports / administers document control system, including revision and maintenance of lab documents to ensure...Hourly payPart timeWork at officeLocal areaFlexible hoursKarius, Inc.
Redwood City, CA3 days ago$41 per hour
Job Summary Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined...Full timeAlexza / Ferrer
Fremont, CA4 days ago- Bionova Scientific LLC in Fremont, CA is seeking a GMP Quality Assurance Compliance professional to lead supplier qualification, self-inspection and client/audit readiness initiatives. The role requires 5+ years in GMP QA, strong data analysis, and experience with ERP/eQMS...
- Protagonist Therapeutics is seeking a Specialist/Sr. Specialist, Quality Assurance to perform GMP QA activities supporting manufacturing. The role reports to the Head of QA and prioritizes QA GMP support with a risk-based approach, including batch record and deviation...Work at office
- Steri-Tek is seeking a Quality Specialist I for our onsite team in Fremont, CA. This entry-level role supports QA activities, document reviews, and ISO/Regulatory compliance tasks under the Quality Management team. You will assist audits, respond to customer inquiries...
$105k - $129k
Ardelyx is seeking a Quality Assurance Specialist III, Analytical to lead review and approval of analytical quality documentation for commercial and clinical products, collaborating with CMOs and internal teams. This hybrid role is based in Newark, CA, requiring 2-3 days...- Bio-Techne is seeking a Quality Assurance Specialist to ensure that quality requirements are met and to support continuous improvement. The role... ...validation activities to uphold ISO 13485 and FDA Quality System requirements. Strong communication, analytical, and organizational...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Assurance Officers. Be the first to apply!
