Job Description
Join our team as a Quality Control Specialist, responsible for ensuring compliance with internal and external regulatory requirements, including FDA, ISO, and MDD standards. You will play a pivotal role in developing an optimal Quality Management System (QMS) that meets business needs and supports new product development.
ResponsibilitiesEnsure QMS compliance with internal and external regulatory requirements.Engage in the development of future state QMS for business needs.Drive improvements and inputs into the quality planning process.Execute development and/or modification of the QMS.Manage Management Review and Quality Planning Review forums.Assess and quantify requirements to optimize QMS structure.Promote GMP and GDP within the Quality organization.Identify and implement improvement opportunities to enhance QMS efficiency.Develop and deliver QMS training.Contribute to the development and maintenance of policies and procedures.Implement best-in-class practices and benchmark against industry leaders.Facilitate communication with notified bodies.Ensure QMS reflects business needs and supports NPD requirements.Participate in relevant QMS IS discussions.Contribute to QMS business processes and understand IS system support.Conduct internal and external quality system audits.Perform IS change control assessment and approval.Essential SkillsExperience with medical device product development lifecycle, including risk management and design/process verification and validation.Applied knowledge of Advanced Quality tools such as FMEA, GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.Ability to read and interpret CAD drawings.Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).Thorough knowledge of US and International Medical Device Regulations.Strong knowledge of Quality Concepts like CAPA, Audits, and Statistics.Strong project management skills with the ability to manage multiple tasks simultaneously.Ability to advocate for product excellence and quality.Experience working cross-functionally with departments such as Advanced Operations, Product Development, Regulatory Affairs, and Marketing.Strong interpersonal, written, oral communication, and negotiation skills.Critical thinking and problem-solving skills.Analytical skills.Ability to manage and complete projects in a matrix organization.Ability to work independently.Experience in compliance risk situations.Computer literacy, including proficiency with Mini-Tab or similar analysis programs.Additional Skills & QualificationsDocument control knowledge.Familiarity with QMS, ECO's, and ECR's.Understanding of Medical Device Regulations.Work Environment
Enjoy a supportive work environment with 2 weeks of PTO and 10 paid holidays. Work with advanced technologies and collaborate with various departments to ensure quality excellence.
Pay and BenefitsThe pay range for this position is $40.00 - $55.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Irvine,CA.
Application Deadline
This position is anticipated to close on Jul 28, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.