Current jobs related to Director of Quality Assurance - Oakland - Medix™

  • Director of Quality Assurance

    1 week ago

    Oakland, California, United States Voyage Foods Full time

    About the RoleWe are seeking a highly experienced and skilled Director of Quality Assurance to lead our quality assurance and food safety initiatives within our rapidly growing food manufacturing organization.Key ResponsibilitiesOversee company-wide quality assurance and ensure compliance with regulatory standardsMentor the QA team and foster a culture of...

  • Director of Quality Assurance

    1 month ago

    Oakland, United States Voyage Foods Full time

    Who We AreWe're a food company using sustainable ingredients and thoughtful food science to replicate our favorite foods in ways that make them more affordable, less harmful, and really, truly just as delicious. We believe that in our best future, the best foods - the ones we love the most - will not just be earth-friendly, but also easy to afford and hard...

  • Director of Quality Assurance

    2 months ago

    Oakland, United States Voyage Foods Full time

    Job DescriptionJob DescriptionWho We AreWe’re a food company using sustainable ingredients and thoughtful food science to replicate our favorite foods in ways that make them more affordable, less harmful, and really, truly just as delicious. We believe that in our best future, the best foods - the ones we love the most - will not just be earth-friendly,...

  • Director of Quality Assurance

    7 hours ago

    Oakland, California, United States Nevados Full time

    About NevadosNevados is a leading solar tracker company that specializes in innovative all-terrain trackers paired with a comprehensive software suite. Our mission is to optimize solar performance, improve plant reliability, and respect the natural landscape.Job OverviewWe are seeking an experienced Quality leader to develop, implement, and manage quality...

  • Quality Assurance Lead

    4 weeks ago

    Oakland, California, United States Lao Family Community Development, Inc. Full time

    Job OverviewLao Family Community Development, Inc. (LFCD) is a non-profit organization dedicated to community enhancement, established in 1980. With a mission to serve diverse populations, LFCD operates across multiple counties, providing essential services in various languages.Position Summary: Reporting to the CEO and/or Director of Programs, the Quality...

  • Quality Assurance Lead

    4 weeks ago

    Oakland, California, United States Lao Family Community Development, Inc. Full time

    Job OverviewLao Family Community Development, Inc. (LFCD) is a non-profit organization dedicated to community advancement, established in Richmond, California, in 1980. Over the years, LFCD has broadened its reach to include services in Alameda and Sacramento counties, with its headquarters located in Oakland, CA. The organization operates across multiple...

  • Quality Assurance Lead

    4 weeks ago

    Oakland, California, United States Lao Family Community Development, Inc. Full time

    Job OverviewLao Family Community Development, Inc. (LFCD) is a dedicated non-profit organization focused on community advancement, established in the City of Richmond. Over the years, LFCD has broadened its reach, now serving multiple counties with a commitment to delivering programs in numerous languages. Our mission is to support diverse populations,...

  • Quality Assurance Manager

    1 month ago

    Oakland, United States Lao Family Community Development, Inc. Full time $71,500 - $90,000

    Job DescriptionJob DescriptionLao Family Community Development, Inc. (LFCD) is a community development non-profit agency established in the City of Richmond in Contra Costa County in 1980. Today, Lao Family has expanded its operations and service footprint to two additional counties including Alameda and Sacramento. LFCD’s headquarters office is in...

  • Quality Assurance Manager

    5 days ago

    Oakland, United States Lao Family Community Development, Inc. Full time

    Job DescriptionJob DescriptionLao Family Community Development, Inc. (LFCD) is a community development non-profit agency established in the City of Richmond in Contra Costa County in 1980. Today, Lao Family has expanded its operations and service footprint to two additional counties including Alameda and Sacramento. LFCD’s headquarters office is in...

  • Senior Director of Healthcare Services and Quality Assurance

    3 weeks ago

    Oakland, California, United States Center for Elders Independence Full time

    Job SummaryCenter for Elders Independence is seeking a highly experienced and skilled Executive Director of Clinical Operations and Process Improvement to lead our clinical care and direct participant service programs. This senior leadership role will be responsible for providing strategic direction and oversight to ensure the delivery of high-quality,...

  • Quality Assurance Specialist

    1 month ago

    Oakland, United States WestCoast Children's Clinic Full time

    Job DescriptionJob DescriptionWestCoast Children's Clinic, located in Oakland, California, is a non-profit community psychology clinic that provides mental health services to Bay Area children, youth and families. Working at WestCoast Children's Clinic means being part of an organization that is client-centered, trauma-informed, collaborative, and...

  • Quality Assurance Supervisor

    4 weeks ago

    Oakland, Mississippi, United States Ajinomoto Windsor, Inc. Full time

    Position Overview:The Quality Assurance Supervisor will play a pivotal role in overseeing the Quality Assurance and Food Safety operations at our facility. This position is crucial in ensuring compliance with the organization's standards, regulatory requirements, and best practices in food safety.Key Responsibilities:The Quality Assurance Supervisor will...

  • Quality Assurance Technician

    6 days ago

    Oakland, California, United States Yoh Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Technician to join our team at Yoh. As a Quality Assurance Technician, you will be responsible for ensuring the quality and safety of our products throughout the manufacturing process.Key ResponsibilitiesConduct quality control checks on products and equipment to ensure compliance with food safety...

  • Quality Assurance Manager

    2 weeks ago

    Oakland, Iowa, United States OSI Industries Full time

    Job SummaryWe are seeking a highly skilled and experienced Quality Assurance Lead to join our team at OSI Industries. As a key member of our quality control department, you will be responsible for leading the testing and quality assurance processes to ensure the highest standards of quality and safety in our products.Key ResponsibilitiesTrain and supervise...

  • Quality Assurance Technician

    6 hours ago

    Oakland, California, United States Yoh Full time

    Job Title: QA Technician IYoh is seeking a highly motivated and detail-oriented QA Technician I to join our team in Oakland, CA.Job Summary:We are looking for a skilled QA Technician I to perform quality control and assurance tasks in a food manufacturing environment. The successful candidate will be responsible for testing and recording ingredient quality...

  • Quality Assurance Manager

    6 days ago

    Oakland, California, United States Lao Family Community Development, Inc. Full time

    Job Title: Quality Assurance ManagerLao Family Community Development, Inc. is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our management team, you will be responsible for ensuring the highest level of quality in our programs and services.Key Responsibilities:Develop and implement quality plans, policies, and system...

  • Quality Assurance Specialist

    3 weeks ago

    Oakland, California, United States Bracane Company Full time

    Job SummaryBracane Company is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for planning, organizing, and directing quality management processes and systems within our organization.Key ResponsibilitiesQuality Management: Develop and implement quality management processes and...

  • Quality Assurance Supervisor

    3 weeks ago

    Oakland, Iowa, United States OSI Group Full time

    Job SummaryThis role will support the Food Safety and Quality Assurance (FSQA) processes, which may include day-to-day food safety and quality assurance functions, along with raw materials and ingredients management and reviewing supporting documents as they pertain to preshipment.Key ResponsibilitiesManage and oversee the FSQA team, including hiring,...

  • Quality Assurance Manager

    2 weeks ago

    Oakland, Mississippi, United States Ajinomoto Foods North America Full time

    Job Title: Assistant FSQA ManagerAt Ajinomoto Foods North America, we are seeking a highly skilled and experienced Assistant FSQA Manager to join our team. This role will play a critical part in ensuring the quality and safety of our products, while also driving compliance with regulatory requirements.Key Responsibilities:Support the Senior Manager, FSQA in...

  • Quality Assurance Engineer

    2 weeks ago

    Oakland, California, United States Magna International Full time

    About the RoleThe Supplier Quality Engineer is a critical position that requires strong communication and problem-solving skills. This role involves interfacing with suppliers and driving quality improvements to ensure customer requirements are met.Key ResponsibilitiesPrepare and maintain quality documentation, including APQP, FMEA, and PPAP.Coordinate and...

Director of Quality Assurance

4 months ago

Oakland, United States Medix™ Full time

Primary Duties and Responsibilities:

  • Providing regulatory and quality consultation as a subject matter expert.
  • Providing both Regulatory and Quality training to Investigators, CTP team members, and at large training.
  • Understanding regional, provincial, and federal laws that apply to the region.
  • Writing clear, informative reports that highlight the main findings.
  • Discussing quality standards and how to accomplish them with other employees.
  • Understanding customer needs and requirements to develop effective quality control processes.
  • Submitting reports and communicating with IRB and regulatory agencies.
  • Staying abreast of developments in GCP and federal regulations regarding clinical research.
  • Assisting with QC and QA of various study-related regulatory documents and reports.
  • Assisting with the training and mentoring of junior regulatory specialists and departmental QC and QA activities.
  • Ensuring quality management system requirements are effectively established and maintained per GCP and Human Subject Protection standard regulations.
  • Leading the development and execution of quality policy, objectives, and strategic plans.
  • Directing and overseeing all Quality Systems staff and functions in areas including FDA and ICH regulations and guidelines, document control, management review, corrective and preventive actions (CAPA), deviations, change control, internal audits, employee training, supplier management, risk management activities, application validation documentation, surveillance, and complaints.
  • Serving as lead contact for inspections by regulatory agencies and sponsor audits.
  • Developing, reviewing, strengthening, and approving all CTP-controlled documents including policies, SOPs, validation documents, change control, deviations, and CAPAs.
  • Developing, planning, and leading readiness for inspections and audits at CTP by GCP and GxP regulatory authorities, clinical investigator sites, and contract organizations.
  • Conducting data auditing and review in support of regulatory submissions and periodic safety reports.
  • Chairing and coordinating quality management review meetings and overseeing action items.
  • Ensuring completion of all corrective actions associated with the quality system and ensuring that the CAPA process is compliant with regulatory requirements.
  • Ensuring all deviations are investigated, closed, tracked, trended, and checked for effectiveness.
  • Leading in developing CTP staff with a set of tools and training to conduct effective root cause analysis.
  • Reporting quality compliance metrics to CTP officers and providing recommendations for improvements.
  • Overseeing and performing audit processes, including managing audit resources, tracking the status of audit findings to closure, and audit record retention.
  • Assisting with the regulatory submissions made to FDA and all other regulatory agencies to obtain clinical approvals and respond to inquiries.
  • Performing other duties related to providing quality program direction and to the mission, goals, and values of CTP.

Required Qualifications:

  • Bachelor's degree with an additional 10 years of progressively responsible experience in managing quality compliance/assurance functions. A master's degree may substitute for two years of experience.
  • Comprehensive knowledge of FDA, ICH, EMEA regulations, and guidelines.
  • Minimum five years in a quality management role with direct reports.
  • In-depth knowledge of 21 Code of Federal Regulation Parts 11, 312, and 820, and experience with Quality Management Systems.
  • Demonstrated experience identifying areas for improvement and implementing solutions, ensuring compliance with standards, regulations, and company procedures, and administering successful programs within appropriate timelines.
  • Experience conducting training for quality assurance and/or regulatory affairs.
  • Ability to interact positively with all levels of staff and external contacts.
  • Proficiency in Microsoft Word, Outlook, Excel, and PowerPoint.
  • Excellent verbal and written communication skills.
  • Experience adopting a flexible, proactive, and service-oriented approach.
  • Travel may be required.

Desired Knowledge, Skills, and Abilities:

  • Certification in regulatory affairs, quality assurance, or clinical research. ASQ (American Society for Quality) Certification is preferred.
  • Experience with onsite monitoring.
  • Expert planning and organization skills.
  • Strong attention to detail.
  • Exceptionally team-focused, actively contributes to a positive and innovative work environment.
  • Able to demonstrate the highest ethical standards, promotes trust, respect, and integrity.
  • Spanish language skills are a plus.