Sr. Director, Quality Assurance

1 week ago

newark, United States I.T. Solutions, Inc. Full time

Role: Sr. Director, Quality Assurance

Location: Newark, CA

Type: Contract to hire or FTE


Job Summary: The Senior Director of Quality Assurance will maintain and lead the implementation of our Quality Management System (QMS) for client projects. He/she will work collaboratively with project leadership and other team members to develop, coordinate, and own the QMS elements of a project. These will include all applicable QMS deliverables related to product planning, design and development, engineering builds, clinical builds, and transfer to manufacturing.


Responsibilities

  • Provide project teams with the guidance necessary to maintain a high level of QMS compliance
  • Ensure that project quality planning is consistent with project objectives and delivers a Quality Management Responsibilities Plan for individual projects as needed
  • Ensure that project quality activities are efficient and effective and performed in a proactive manner
  • Oversee the generation and maintenance of quality records that are consistent withQMS
  • Ensure that project records are maintained in a state of readiness for external audits and regulatory inspections
  • Maintain and regularly update library of applicable technical, quality, and risk management standards
  • Maintain ISO 13485 certification, including managing internal audits
  • Develop SOPs, work instructions, guidance documents and templates to drive compliance and to facilitate dissemination of best practices related to quality management systems
  • Support QMS related training and professional development for scientific and technical staff
  • Own the Quarterly Management Review process, managing and reporting project and operational quality metrics to management
  • Provide input to quality-related strategic planning to meet short and long term business goals
  • Provide management with objective evaluation of overall quality performance and guidance for implementation of improvements
  • Actively participate in developing and deploying effective continuous improvement of quality management processes
  • Serve as the QMS Management Representative, interfacing with the ISO Registrar and with Regulatory Agencies as necessary
  • Manage Document Control function
  • Education, Experience, and SkillsMinimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced degree preferred
  • ASQ and RAPS Certifications are a plus (e.g., Quality Engineer, Certified Quality Manager)
  • ISO 13485 – Lead Assessor Certification preferred
  • Knowledge and experience with advanced quality systems concepts
  • In-depth knowledge of current regulatory expectations, quality and compliance processes, operations and strategy
  • Demonstrated knowledge of interpretation and application of QSR, EU MDR, ISO 13485, and other applicable regulations and standards
  • Minimum three (3) years of active senior quality management and leadership experience; and minimum ten (10) years related experience in an FDA regulated environment
  • Experience in design, manufacturing, or technical support for medical devices or other technically complex or regulated products
  • Working knowledge of engineering design and build practices
  • Working knowledge of basic assembly and manufacturing processes
  • Progressive QA/QC leadership experience, including "hands-on” detailed quality systems development and experience managing implementation of quality functions
  • Current knowledge of applicable quality and regulatory requirements and trends including risk-based compliance requirements
  • Active participation or thought leadership through ASQ or similar professional organizations addressing quality systems practices
  • Demonstrated expertise in interpretation and pragmatic application of quality standards
  • Desired skills:Strong technical and conceptual aptitude in quality systems coupled with "out of the box” strategic thinking
  • Strong leadership ability and superior interpersonal and communication skills championing the overall mission of quality
  • Ability to take initiative in applying innovative approaches to quality solutions in a fast paced and highly varied environment
  • Ability to provide alternatives including exploring new information and external insights without compromising compliance
  • Demonstrated ability to influence areas not under direct control and effectively communicate goals and objectives
  • Ability to work in a matrix environment and build relationships based on confidence rather than authority
  • Capability to build alignment amidst diverse perspectives ranging from research & development to engineering to manufacturing
  • Strong planning and implementation capabilities
  • Ability to make and act on sound fact-based decisions while balancing time-constraints, quality, and risk
  • Comfortable with electronic documentation/records systems and strong general office computing skills, including experience with creating Microsoft Office templates


The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

  • Sr. Director, Quality Assurance

    2 weeks ago

    Newark, United States I.T. Solutions, Inc. Full time

    Role: Sr. Director, Quality AssuranceLocation: Newark, CAType: Contract to hire or FTEJob Summary: The Senior Director of Quality Assurance will maintain and lead the implementation of our Quality Management System (QMS) for client projects. He/she will work collaboratively with project leadership and other team members to develop, coordinate, and own the...

  • Sr. Director, Quality Assurance

    7 days ago

    newark, United States I.T. Solutions, Inc. Full time

    Role: Sr. Director, Quality AssuranceLocation: Newark, CAType: Contract to hire or FTEJob Summary: The Senior Director of Quality Assurance will maintain and lead the implementation of our Quality Management System (QMS) for client projects. He/she will work collaboratively with project leadership and other team members to develop, coordinate, and own the...

  • Sr. Director, Quality Assurance

    3 days ago

    Newark, United States I.T. Solutions, Inc. Full time

    Role: Sr. Director, Quality AssuranceLocation: Newark, CA (Onsite)Type: Contract to hire or FTEJob Summary: The Senior Director of Quality Assurance will maintain and lead the implementation of our Quality Management System (QMS) for client projects. He/she will work collaboratively with project leadership and other team members to develop, coordinate, and...

  • Director, Quality Assurance, Quality Assurance

    2 weeks ago

    Newark, United States Amazon.com Full time

    At Audible, we believe stories have the power to transform lives. It’s why we work with some of the world’s leading creators to produce and share audio storytelling with our millions of global listeners. We are dreamers and inventors who come from a wide range of backgrounds and experiences to empower and inspire each other. Imagine your future with...

  • Senior Director Quality Assurance

    2 weeks ago

    newark, United States I.T. Solutions, Inc. Full time

    Role: Sr. Director, Quality Assurance Location: Newark, CAType: Contract to hire or FTE Job Summary: The Senior Director of Quality Assurance will maintain and lead the implementation of our Quality Management System (QMS) for client projects. He/she will work collaboratively with project leadership and other team members to develop, coordinate, and own the...

  • Senior Director Quality Assurance

    2 weeks ago

    Newark, United States I.T. Solutions, Inc. Full time

    Role: Sr. Director, Quality Assurance Location: Newark, CAType: Contract to hire or FTE Job Summary: The Senior Director of Quality Assurance will maintain and lead the implementation of our Quality Management System (QMS) for client projects. He/she will work collaboratively with project leadership and other team members to develop, coordinate, and own the...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Newark, Delaware, United States Revance Full time

    Job SummaryThe Sr. Specialist, Quality Assurance is an intermediate level position with hands-on QA experience. Under moderate supervision, the individual will be working in the Quality Systems team for providing quality oversight of the lifecycle management of GxP Facilities, Utilities, Equipment, Analytical Instruments, and Computerized Systems. The...

  • Sr. Director for Benefits and Compensation

    2 days ago

    Newark, United States Friends Services Alliance Full time

    The Kendal Corporation Newark DE Full Time Join an organization where you can make a difference! Kendal ~ Together, transforming the experience of aging. The Sr. Director for Benefits and Compensation functions as a senior advisor and trusted partner to the business on system-wide organization, benefit, and compensation strategies. Collaborating with...

  • Sr. Director People Analytics

    2 weeks ago

    Newark, United States SBM Management Services Full time

    Sr. Director People Analytics Corporate Leadership Jobs St. Louis, Missouri Sacramento, California Dallas, Texas Newark, New Jersey Description Position at SBM Management SBM is searching for an experienced and well-organized Sr. Director People Analytics to join our team!The Sr. Director of People Analytics will lead the strategy, execution, and...

  • Quality Assurance Specialist

    4 weeks ago

    Newark, Delaware, United States destinationone Consulting Full time

    Quality Assurance Coordinatordestinationone Consulting is a leading recruitment agency specializing in diverse sectors, including Healthcare, Health Tech, Government, Municipalities, NonProfits, Legal, and Public Accounting. We are building a comprehensive database of opportunities in these fields. By applying, you enable our recruiters to quickly match you...

  • Quality Assurance Auditor

    3 weeks ago

    Newark, Delaware, United States QPS, LLC Full time

    At QPS, LLC, we are seeking a highly detail-oriented and organized Quality Assurance Auditor to join our team. As a key member of our QA team, you will be responsible for ensuring compliance with applicable regulatory guidelines and requirements.Key Responsibilities:Maintain client confidentiality and ensure that any documents received for audit are...

  • Quality Assurance Specialist

    3 weeks ago

    Newark, New Jersey, United States Meet Full time

    Job Title: Quality Assurance SpecialistDepartment: Quality AssuranceCategory: Quality and RegulatoryJob Summary:We are seeking a Quality Assurance Specialist to support our client's innovative biotechnology company. This position offers hands-on experience in quality systems, reserve sample programs, and incoming attribute inspections. You'll work...

  • Quality Assurance Specialist

    4 weeks ago

    newark, United States Meet Full time

    Job Title: Quality Assurance Specialist IIDepartment: Quality AssuranceCategory: Quality and RegulatoryJob Summary:We are seeking a Quality Assurance Specialist II to join our client's innovative biotechnology company. This intermediate-level position offers hands-on experience in quality systems, reserve sample programs, and incoming attribute inspections....

  • Quality Assurance Specialist

    4 weeks ago

    newark, United States Meet Full time

    Job Title: Quality Assurance Specialist IIDepartment: Quality AssuranceCategory: Quality and RegulatoryJob Summary:We are seeking a Quality Assurance Specialist II to join our client's innovative biotechnology company. This intermediate-level position offers hands-on experience in quality systems, reserve sample programs, and incoming attribute inspections....

  • Quality Assurance Specialist

    4 weeks ago

    Newark, United States Meet Full time

    Job Title: Quality Assurance Specialist IIDepartment: Quality AssuranceCategory: Quality and RegulatoryJob Summary:We are seeking a Quality Assurance Specialist II to join our client's innovative biotechnology company. This intermediate-level position offers hands-on experience in quality systems, reserve sample programs, and incoming attribute inspections....

  • Quality Assurance Specialist

    3 weeks ago

    Newark, Delaware, United States ViaSat Full time

    About ViasatViasat is a leading provider of global communication services, and we're seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.Key ResponsibilitiesPerform thorough inspections of products to ensure they meet our quality...

  • Quality Assurance Specialist

    3 weeks ago

    Newark, Delaware, United States Hologic Full time

    Quality Assurance SpecialistAt Hologic, we are seeking a highly skilled Quality Assurance Specialist to join our team in Newark, DE. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our medical devices and ensuring compliance with regulatory requirements.Key Responsibilities: Process and evaluate product returns for our...

  • Quality Assurance Specialist

    4 weeks ago

    Newark, New York, United States ViaSat Full time

    About ViasatViasat is a leading provider of satellite-based communication solutions. We're on a mission to deliver connections that change the world.Job SummaryWe're seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.Key...

  • Quality Assurance Specialist

    4 weeks ago

    Newark, Delaware, United States ViaSat Full time

    About UsViasat is a leading provider of satellite-based communications solutions. We're committed to delivering high-quality products and services that meet the needs of our customers.Job SummaryWe're seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring that our products meet the...

  • Quality Assurance Specialist

    4 weeks ago

    Newark, New York, United States ViaSat Full time

    About ViasatViasat is a leading provider of global communication solutions. We're on a mission to deliver connections that change the world.As a Quality Assurance Specialist, you will be a key member of our quality assurance team, embedded at our supplier facilities. Your primary responsibilities will include:Performing thorough inspections of products...