Quality Assurance Specialist – (Medical Device)

JOB FUNCTION: Scientific
JOB TYPE: Direct Hire
COMPENSATION: $70k - $80k
POSTED: Nov 10, 2022

Our client is one of the leading Consumer Product company that manufactures Baby and Toddler feeding and care products. This company is known for being passionate about creating quality products, innovative, modern and having a fast paced environment and they are looking to hire a Quality Assurance Specialist – (Medical Device) who will be implementing and improving a developing quality management system.

Salary/Hourly Rate:

$70,000 – $80,000 Dependent on experience

Position Overview:

The  Quality Assurance Specialist – (Medical Device) will be working directly with a multiple departments such as  Product Development, Patent, Marketing, Legal  to bring high-quality, innovative products from concept to commercialization. The Quality Assurance Specialist – (Medical Device) will be the subject matter expert focused on Medical Device products responsible for  the quality, safety and Company policies and procedures to ensure compliance with world markets, internal company, quality requirements, and customer/retailer requirements.

Responsibilities of the Quality Assurance Specialist – (Medical Device):

  • 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
  • Work with Product Development & Engineering teams for recommendations to minimize or eliminate the possibility of hazardous conditions
  • Review and assess new product designs to ensure compliance to appropriate Global government, industry, and retailer requirements
  • Communicate with the customer’s QA, Safety and Compliance representatives to ensure that the customer’s product requirements are completely understood
  • Work with external 3rd party testing labs and other accredited testing facilities
  • Assist in  medical device design & development and advise on risk management activities
  • Work with Global counterparts to ensure that procedures are properly understood and followed
  • 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
  • Review product markings, installation/assembly instructions, warning labels and packaging to ensure compliance to applicable standards
  • Other duties may be assigned

Qualifications for the Quality Assurance Specialist – (Medical Device):

  • 3 to 5 years of related quality assurance or equivalent combination of education and experience or related experience in medical device
  • Knowledge of applicable regulations, standards, and laws including: CPSIA, CHPA, CFR, UL, ETL, FDA, ASTM, and EN
  • Knowledgeable in 21 CFR 820 and ISO 13485 requirements
  • Knowledge in international standards and FDA guidance documents for medical electrical equipment
  • Ability to handle multiple competing priorities
  • Flexible and able to work in a  fast-paced environment

Education Requirements:

  • Bachelor’s degree in Engineering, Scientific or Business field is preferred


  • Medical, Dental, and Vision
  • Life insurance coverages
  • Wellness benefits
  • Generous employer-matched 401k plan
  • Bonuses
  • Opportunities to earn equity
  • Paid maternity and paternity leave
  • Hybrid work from home schedule
  • Annual weeklong global office closures
As a woman-owned firm, we value diversity. We are an equal opportunity employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Position ID: 115942