Design Quality Engineer

Actalent; Irvine (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

Actalent is seeking a Design Quality Engineer I to develop quality assurance documentation and maintain the design control process for new product development. This onsite role focuses on risk management and collaboration with various departments, ensuring compliance with medical device regulations. Candidates should have experience with statistical analysis and strong problem-solving skills to excel in this position.

Benefits

401(k) Retirement Plan

Medical, dental & vision insurance

Employee Assistance Program

Short and long-term disability

Transportation benefits

Time Off/Leave (PTO, Vacation or Sick Leave)

Qualifications

• Experience with medical device product development lifecycle.
• Ability to read and interpret CAD drawings.
• Experience interacting with regulatory agencies (FDA, MoH, etc.).

Responsibilities

• Develop quality assurance documentation for new product development.
• Maintain quality system by correcting deficiencies.
• Engage in risk management activities and design reviews.

Skills

Risk management

Design verification and validation

Statistical analysis

Problem-solving

Interpersonal skills

Job description

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Job Description

The Design Quality Engineer I will be responsible for developing quality assurance documentation to support new product development and regulatory submissions. This role requires maintaining the quality system for the design control process by identifying and correcting deficiencies in procedures and practices. The engineer will engage in design, development, manufacturing, and risk management activities for new product development projects, ensuring efficient testing practices and supporting the definition of design verification and validation test requirements.

Job Title: Design Quality Engineer I

Job Description

The Design Quality Engineer I will be responsible for developing quality assurance documentation to support new product development and regulatory submissions. This role requires maintaining the quality system for the design control process by identifying and correcting deficiencies in procedures and practices. The engineer will engage in design, development, manufacturing, and risk management activities for new product development projects, ensuring efficient testing practices and supporting the definition of design verification and validation test requirements.

Responsibilities

• Develop quality assurance documentation for new product development and regulatory submissions.
• Maintain quality system for design control by identifying and correcting deficiencies.
• Engage in design, development, manufacturing, and risk management activities.
• Participate in design reviews, identifying risks and tracking mitigation measures.
• Define design verification and validation test requirements and complete reports with statistical validity.
• Support Advanced Operations in developing manufacturing processes for new products.
• Utilize statistical analysis and problem-solving techniques to determine product acceptance limits and resolve quality issues.
• Develop, review, and approve inspection plans, routers, and product drawings.
• Support product design transfers to manufacturing facilities.
• Evaluate predicate products for relevant quality issues impacting new product development.
• Analyze and define critical quality attributes through risk analysis techniques.
• Collect initial market feedback and address early concerns.
• Lead risk management activities by developing risk management plans and conducting risk reviews.
  
  

Essential Skills

• Experience with medical device product development lifecycle, including risk management and design/process verification and validation.
• Applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (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 project management skills and ability to manage multiple tasks.
• Advocacy for product excellence and quality.
• Ability to work cross-functionally with departments such as Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
• Strong interpersonal, written, oral communication, and negotiation skills.
• Critical and 'outside the box' thinking.
• Problem-solving and 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 & Qualifications

• Strong knowledge of Quality Concepts such as CAPA, Audits, and Statistics.
• Demonstrated ability to effectively manage multiple tasks simultaneously.
• Demonstrated ability to advocate for product excellence and quality.
• Strong interpersonal skills and ability to work cross-functionally.
  
  

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 Jun 23, 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 [e-mail] for other accommodation options.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Business Consulting and Services

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