Product Quality Assurance Specialist

4 weeks ago

Van Nuys, United States Munchkin Full time

Job Summary:

The Quality Assurance Engineer will play a key role in ensuring the overall regulatory, quality, safety, and reliability of Company policies and procedures to comply with world markets including US, Canada, Latin America, Asia, and European regulations, internal company quality requirements, and customer/retailer requirements focused on electronics.

Key Responsibilities:

  • Review and assess new product designs to ensure compliance to appropriate Global government, industry, and retailer requirements
  • Interact closely with Product Development & Engineering teams and make recommendations to minimize or eliminate the possibility of hazardous conditions
  • Communicate with the customer's QA, Safety, and Compliance representatives to ensure that the customer's product requirements are completely understood
  • Develop strong business relationships and work closely with key external 3rd party testing labs and other accredited testing facilities
  • Assist in medical product and process verification and validation activities
  • Assist in medical device design & development and risk management activities
  • Coordinate with Asia and UK Personnel to ensure that procedures are properly understood and followed
  • Evaluate and test prototypes, models, and pre-production samples for safety and fit, form, and function
  • Stay current and attend training as needed on all regulatory issues, information from test labs, regulatory groups, and customer-specific requirements
  • Coordinate all independent test lab activities, and interventions, review reports, and establish any corrective actions
  • Responsible for tracking and communicating the status of all component and product testing
  • Coordinate pre-production and final lab testing process to ensure pass test results in an efficient manner
  • Maintain, manage, and review testing reports (including pre-production and final testing) for all products to ensure an accurate, complete, and easily accessible archive. Advise on retesting as appropriate
  • Review product markings, installation/assembly instructions, warning labels, and packaging to ensure compliance with applicable standards
  • Establish and manage corrective action processes to resolve manufacturing defects and product improvement activities

Requirements:

  • Bachelor's degree in Engineering, Electronic field preferred
  • 3-5 years of related experience and/or training in medical device quality assurance or equivalent combination of education and experience
  • Electronic quality experience is a must
  • Medical device quality experience preferred, including working knowledge of 21 CFR 820 and ISO 13485 requirements
  • Knowledge of applicable regulations, standards, and laws including: CPSIA, CHPA, CFR, UL, ETL, FDA, ASTM, and EN
  • Ability to handle multiple competing priorities and adapt to a flexible and fast-paced environment

About Munchkin:

Munchkin is a leading consumer product company and most loved baby lifestyle brand behind innovative gear and products for children, mothers, and caregivers. We have sold billions of dollars of products through our key retail partners: Target, Walmart, and Amazon, and have global distribution in over 50 countries. Our vision is to establish an expanding portfolio of innovative businesses that align with our commitment to inventive product design.

Why Work at Munchkin:

We offer a comprehensive benefits package that includes medical, vision, dental, prescription drug coverage, life insurance, wellness benefits, a generous employer-matched 401(k) plan, and Paid Childcare Leave, among other benefit plans. Our total rewards are top of the market and include competitive salary, bonus, and opportunities to earn equity. We focus on supporting employee development and growth, and regularly hold social functions to foster a genuine camaraderie that enhances teamwork.

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