Description
\t\t\t\t\tDevelop quality assurance documentation to support new product development process and regulatory submissions. Support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices. Engage in the design, development, manufacturing, and risk management activities for new product development projects. Engage in design reviews by identifying risks associated with the product used and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process. Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria. Complete final design verification and validation reports by providing concise conclusions with statistical validity and graphical support. Promote efficient testing practices. Support Advanced Operations in the development of manufacturing processes for new products. Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc. Develop, review, and approve inspection plans, routers, and product drawings for new products. Support product design transfers to internal and/or external manufacturing facilities. Evaluate predicate products for relevant quality issues tthat may impact new product development projects. Analyze and define critical quality attributes for product and process through risk analysis techniques. Participate in collection of initial market feedback on new products and address early concerns. Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
\t\t\t\t\tSkills
\t\t\t\t\tMedical device, Quality assurance, Risk management, Quality management system, Design control, Design, Validation
\t\t\t\t\tTop Skills Details
\t\t\t\t\tMedical device
\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\tPrefer experience with medical device product development lifecycle, including risk management and design/process verification and validation. Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke. Demonstrated ability to read and interpret CAD drawings. Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required. Thorough knowledge and understanding of US and International Medical Device Regulations. Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics). Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously. Demonstrated ability to advocate for product excellence and quality. Demonstrated ability to effectively work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing. Strong interpersonal skills, written, oral communication and negotiations skills. Strong in critical thinking and \"outside the box\" thinking. Highly developed problem solving skills. Strong analytical skills. Demonstrated ability to successfully manage and complete projects in a matrix organization. Demonstrated ability to work independently. Experience in working in a compliance risk situation. Computer literacy (including proficiency with Mini-Tab or similar analysis program).
\t\t\t\t\tExperience Level
\t\t\t\t\tEntry Level
Pay and Benefits
The pay range for this position is $50.00 - $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 May 16, 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.