QA Engineer and FDA Medical Device Specialist
2 days ago
WHY Brands Inc., a parent company of Munchkin and Curio Home Goods, focuses on creating, incubating, and growing the next generation of consumer lifestyle brands. Founded in 1990, Munchkin is the leading consumer product company and most loved baby lifestyle brand behind the innovative gear and products for children, mothers, and caregivers. Munchkin has sold billions of dollars of products through our key retail partners: Target, Walmart, and Amazon and has global distribution in over 50 countries. Curio, a premium brand of curated collections of home goods, launched in 2023. WHY’s vision is to establish an expanding portfolio of innovative businesses that align with its commitment to inventive product design. With over 320+ patents under our belt, we continue to create solutions that leave our customers asking, 'how did I ever live without this?' Recognized as #8 on America’s Most Innovative Companies list by Fortune Magazine, innovation is the core of our company DNA and has been driving our designs for 30 years
We lead with our core values and believe that investing in the community is our responsibility. We create opportunities for every child’s potential and well-being through the Radiant Colors program, work to create a sustainable future, and in partnership with the International Fund for Animal Welfare have committed to animal conservation.
There is no better time than now to join WHY Brands as we embark on our next and biggest growth journey, and you could be the next influential leader to play a key role in driving enormous customer-centered value and rapid growth.
What You’ll Do
The Quality Assurance Engineer’s primary responsibility is to assist with establishing the overall quality, safety and reliability Company policies and procedures to ensure compliance with world markets including US, Canada, Latin America, Asia, and European regulations, internal company quality requirements, and customer/retailer requirements focused on medical devices. This position offers a unique opportunity to implement and improve a developing quality management system while working directly with a multidisciplinary team to bring high-quality, innovative products from concept to commercialization.
- 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, 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, 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 to applicable standards
- Establish and manage corrective action process to resolve manufacturing defect and product improvement activities
- Other duties may be assigned
Bring It
- Bachelor's degree in Engineering, Scientific or Business field preferred
- 3-5 years of related experience and/or training in medical device quality assurance or equivalent combination of education and experience
- Medical device quality experience required, including working knowledge of 21 CFR 820 and ISO 13485 requirements
- Familiarity with international standards and FDA guidance documents for medical electrical equipment
- 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
As a Great Place to Work Certified company, we are committed to offering the best to our employees. We offer a comprehensive benefits package that includes medical, vision, dental, prescription drug coverage, life insurance, wellness benefits, generous employer-matched 401(k) plan, Paid Childcare Leave, among other benefit plans. Our total rewards are top of market and include competitive salary, bonus, and opportunities to earn equity. We focus on supporting employee development and growth.
Munchkin welcomes and values what makes everyone unique. We’re proud to be an equal opportunity and affirmative action employer. All hires for our team are based on qualifications, merit, and business needs. We recruit, employ, train, and promote regardless of race, color, religion, disability, sex, sexual orientation, gender identity, national origin, age, veteran status, genetic characteristic, or any other protected status.
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