Job Description

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

WE GOT YOU COVERED!

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, and life coverages, wellness benefits, generous employer-matched 401(k) plan, bonuses, opportunities to earn equity, and much more.  We focus on supporting employee development and growth. 

We regularly hold social functions to foster a genuine camaraderie that enhances teamwork. At our company-wide award functions, we take time to recognize the talent and dedication of the people who make Munchkin the most loved baby lifestyle brand in the world.

We offer work-life balance benefits such as paid maternity and paternity leave, Hybrid work from home schedule on Tuesday and Fridays, and annual weeklong global office closures giving our people a chance to recharge!

To learn more, visit us at www.munchkin.com. Munchkin embraces diversity and is proud to be an equal opportunity employer.

Security Clearance Required: No

Visa Candidate Considered: No

CANDIDATE DETAILS

2+ TO 5 YEARS' EXPERIENCE

Seniority Level - Associate

Management Experience Required - No

Minimum Education - Bachelor's Degree

Willingness to Travel - Occasionally

IDEAL CANDIDATE

WHO WE ARE

Munchkin is one of the most innovative and fast-growing consumer product companies in the world!  After 30 years of being a leader in the baby industry, Munchkin is growing up and expanding our business reach to even more consumers with the launch of Curio, a highly curated line of home products inspired by curiosity. 

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. 

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

WE GOT YOU COVERED!

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, and life coverages, wellness benefits, generous employer-matched 401(k) plan, bonuses, opportunities to earn equity, and much more.  We focus on supporting employee development and growth. 

We regularly hold social functions to foster a genuine camaraderie that enhances teamwork. At our company-wide award functions, we take time to recognize the talent and dedication of the people who make Munchkin the most loved baby lifestyle brand in the world.

We offer work-life balance benefits such as paid maternity and paternity leave, Hybrid work from home schedule on Tuesday and Fridays, and annual weeklong global office closures giving our people a chance to recharge!

To learn more, visit us at www.munchkin.com. Munchkin embraces diversity and is proud to be an equal opportunity employer.

Company Description

Great Company culture