Senior Quality Assurance Specialist

4 weeks ago

San Diego, California, United States Ignite Human Capital Full time
Job Overview

The Senior Quality Assurance Specialist will oversee key components of the Quality System, focusing on supplier oversight, corrective actions, customer feedback, regulatory compliance, and product release processes.

Key Responsibilities
  • Conduct audits of suppliers as needed to ensure quality standards are met.
  • Develop, review, and validate standard operating procedures (SOPs), testing protocols, and compliance documentation to ensure adherence to regulatory requirements and internal guidelines.
  • Manage quality-related activities, including addressing deviations, non-conformities, and customer feedback.
  • Lead investigations for corrective and preventive actions (CAPAs).
  • Assess and document the impact of deviations and customer complaints on product quality.
  • Review and approve risk analyses related to engineering changes and recalls.
  • Oversee engineering change orders and maintain accurate documentation; collaborate with various teams to resolve quality-related issues.
  • Collaborate with manufacturing teams to integrate risk management practices and ensure compliance throughout the product development lifecycle.
  • Engage in both internal and external compliance audits.
  • Provide ongoing support and training to quality assurance team members.
  • Contribute to the development of training initiatives aimed at enhancing product quality.
  • Analyze quality metrics and trends for continuous improvement.
Additional Responsibilities
  • Plan and prioritize projects aligned with organizational goals.
  • Work with product development teams to ensure adherence to regulatory standards.
  • Perform additional tasks as assigned by management.
Requirements
  • Bachelor's degree in a relevant scientific field or equivalent experience; an engineering degree is preferred.
  • Minimum of 5 years in quality assurance, preferably within the biotech or medical device sectors, with experience in a regulated environment.
Essential Skills
  • Strong understanding of quality assurance processes related to medical products, including testing protocols and statistical methodologies.
  • High integrity and professionalism with a strong work ethic and the ability to work autonomously.
  • Exceptional communication and presentation abilities.
  • Proactive and results-oriented with a strong sense of urgency.
  • Capable of initiating and managing change effectively.
  • Detail-oriented with a high degree of accuracy in data management.
  • Proficient in gathering and analyzing information to resolve issues.
Core Competencies
  • Performance-Driven: Committed to achieving departmental objectives and comfortable with measurable outcomes.
  • Impact-Focused: Aims to contribute meaningfully to organizational goals and positively affect user experiences.
  • Competitive Spirit: Motivated to excel within the industry and support the organization's growth ambitions.
  • Urgency: Demonstrates agility and responsiveness to company goals.
  • Resilience: Maintains composure under pressure and navigates ambiguity effectively.
  • Confidence: Exhibits assurance in skills and pursues tasks with determination.
  • Multitasking Ability: Capable of managing multiple priorities efficiently.

  • Senior Quality Assurance Specialist

    3 weeks ago

    San Diego, California, United States The Swag Bag Team Full time

    We are seeking a skilled Senior Quality Assurance Specialist to be part of our dynamic team at The Swag Bag Team. This role involves ensuring that our software products meet our high standards of quality and reliability before they reach our users.Key Responsibilities:Review and analyze system specifications to ensure clarity and understanding of...

  • Senior Quality Assurance Specialist

    3 weeks ago

    San Francisco, California, United States Saxon Global Full time

    Job Title: Senior Quality Assurance SpecialistAbout the Role:We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Saxon Global. As a Senior Quality Assurance Specialist, you will be responsible for ensuring the quality of our retail systems and applications.Key Responsibilities:Conduct functional testing of retail systems...

  • Senior Quality Assurance Specialist

    3 weeks ago

    San Jose, California, United States SQA Services Full time

    Job Title: Senior Quality Assurance SpecialistOverview:SQA Services is seeking a Senior Quality Assurance Specialist to join our global inspection team, working with a renowned aerospace leader. If you have a keen eye for detail, a commitment to quality, and the ability to maintain high standards in a fast-paced environment, we want to hear from you.Position...

  • Senior Software/Hardware Quality Assurance Specialist

    3 weeks ago

    San Diego, California, United States Leidos Full time

    Job SummaryWe are seeking a Senior Software/Hardware Quality Assurance Specialist to join our team at Leidos. In this role, you will be responsible for conducting quality assurance and testing using Agile methodology, developing and maintaining automated test scripts, and identifying and reporting defects.Key Responsibilities:Conduct quality assurance and...

  • Senior Quality Assurance Specialist

    4 weeks ago

    San Diego, California, United States Ajinomoto Bio-Pharma Services Full time

    Why Work with Us?Ajinomoto Bio-Pharma Services is a leading contract development and manufacturing organization with a strong commitment to improving the health of humankind. We offer a unique work environment where our employees play a crucial role in society.Job SummaryWe are seeking a highly experienced Senior Quality Assurance Specialist to join our...

  • Quality Assurance Specialist

    4 weeks ago

    San Diego, California, United States Senior Plc Full time

    Job Title: Quality InspectorWe are seeking a highly skilled Quality Inspector to join our team at Senior Plc's Jet Products facility in Kearny Mesa. As a Quality Inspector, you will be responsible for ensuring the quality of our products and processes, and contributing to the success of our organization.Key Responsibilities:Perform dimensional and visual...

  • Quality Assurance Specialist

    4 weeks ago

    San Diego, California, United States Top Dogg Staffing Full time

    Quality Assurance SpecialistThe Position Quality Assurance Specialist (Medical Device-Spine) Medical Equipment / Devices Information Technology - Quality AssuranceFull-time United States - California - San Diego - Vista The Compensation $ 80,000 -$91,000 Benefits - FullRelocation Assistance Available - NoCommission Compensation - No Bonus Eligible - Yes...

  • Quality Assurance Specialist

    4 weeks ago

    San Diego, California, United States Senior Plc Full time

    Job Title: Quality InspectorWe are seeking a highly skilled Quality Inspector to join our team at Senior Plc. As a Quality Inspector, you will be responsible for ensuring the quality of our products and processes.Key Responsibilities:Perform dimensional and visual inspections of parts, assemblies, and/or final products.Conduct final inspections of completed...

  • Senior Quality Assurance Specialist

    4 weeks ago

    San Jose, California, United States Virtusa Full time

    Job Title: Senior Quality Assurance SpecialistJob Description:We are seeking a skilled and detail-oriented Senior Quality Assurance Specialist to join our team at Virtusa. The ideal candidate will be responsible for performing manual testing of new features across Android, iOS, and web platforms. The role involves understanding requirement documents,...

  • Quality Assurance Specialist

    3 weeks ago

    San Diego, California, United States Insight Global Full time

    Job Title: Quality Assurance SpecialistAbout the Role:We are seeking a Quality Assurance Specialist to join our team at Insight Global. As a Quality Assurance Specialist, you will be responsible for designing and conducting quality assurance testing to support improvement initiatives for various business systems.Key Responsibilities:* Review requirements and...

  • Quality Assurance Specialist

    3 weeks ago

    San Diego, California, United States Kratos Defense & Security Solutions Full time

    Job Summary:Kratos Defense & Security Solutions is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for designing, developing, and executing quality assurance and control systems.Key Responsibilities:Design and develop quality assurance and control systemsImplement quality concepts,...

  • Senior Quality Specialist

    3 weeks ago

    San Diego, California, United States MILLENNIUMSOFT Full time

    Job Title: Senior Quality SpecialistJob Summary:We are seeking a highly skilled Senior Quality Specialist to join our team at MillenniumSoft. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and complaint management.Key Responsibilities:* Collaborate with clinical, technical, and regulatory employees to determine...

  • Quality Assurance Specialist

    4 weeks ago

    San Diego, California, United States gategroup Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at gategroup. As a Quality Assurance Specialist, you will be responsible for ensuring the highest standards of quality and safety in our Hot Foods Production department.Key ResponsibilitiesConduct temperature checks on products and ensure compliance...

  • Senior Quality Assurance Specialist

    4 weeks ago

    San Diego, California, United States Ajinomoto Bio-Pharma Services Full time

    About the RoleAjinomoto Bio-Pharma Services is seeking a highly skilled Senior Quality Assurance Specialist to join our QA/Compliance team. As a Subject Matter Expert in data management, you will be responsible for assisting in determining systems impacted by data integrity requirements, QA representation on workflow validations, and DI-related risk...

  • Senior Quality Assurance Manager

    4 weeks ago

    San Francisco, California, United States E-Zen Comp Full time

    Job OverviewAs a Senior Quality Assurance Manager, you will be responsible for leading a team of quality assurance specialists in ensuring the highest quality of our products.Key Responsibilities:Manage and lead a team of quality assurance specialistsDevelop and implement quality assurance processes and proceduresCollaborate with cross-functional teams to...

  • Quality Assurance Specialist

    4 weeks ago

    San Diego, California, United States Aerotek Full time

    **Quality Assurance Specialist**At Aerotek, we're seeking a skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the highest quality standards are met in our manufacturing processes. Your expertise will be crucial in developing and maintaining CMM programs, performing product...

  • Quality Assurance Specialist

    4 weeks ago

    San Diego, California, United States CalTek Staffing, Inc. Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at CalTek Staffing, Inc. The ideal candidate will have a strong technical background in mass production processes and quality assurance for the telecommunications industry. This role involves overseeing the end-to-end production and design process, driving continuous...

  • Quality Assurance Specialist

    4 weeks ago

    San Diego, California, United States Aerotek Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Aerotek. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes by performing inspections and implementing effective solutions.Key Responsibilities:Develop and maintain CMM programs for inspecting and...

  • Quality Assurance Specialist

    4 weeks ago

    San Diego, California, United States The Swag Bag Team Full time

    Job OverviewWe are seeking a skilled Quality Assurance Specialist to join our dynamic team at The Swag Bag Team. As a key member of our software development lifecycle, you will play a crucial role in ensuring the quality and reliability of our products.Key ResponsibilitiesReview and analyze system specifications to ensure clarity and understanding of...

  • Quality Assurance Specialist

    3 weeks ago

    San Diego, California, United States Wondfo USA Full time

    Job DescriptionWondfo USA is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring that our medical devices meet the highest quality standards and regulatory requirements.Key Responsibilities:Support and comply with the company's Quality Management System policies...