Quality Assurance Engineer

2 weeks ago


Elkton, Minnesota, United States Manpower Group Inc. Full time
Job Title: Quality Engineer II

We are seeking a highly skilled Quality Engineer II to join our team at Manpower Group Inc. in Elkton, MD. As a Quality Engineer II, you will play a critical role in ensuring that our medical devices meet or exceed customer expectations and requirements.

Key Responsibilities:
  • Investigate and implement best-in-class Quality Engineering practices
  • Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities
  • Establish effective corrective action plans and lead in the implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements
  • Act as an effective project lead or team member in supporting quality disciplines, decisions, and practices
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Identify non-conformance trends and develop technical investigation plans, investigate and analyze customer/internal complaints, perform data analysis and execute experiments to qualify or resolve product and process issues
  • Create, review, and approve internal documentation such as quality plans and standard operating procedures
  • Develop product/process assurance plans, which include all required elements, and identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
  • Responsible for developing and implementing master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA and ISO requirements
Qualifications:
  • Bachelor's degree (4 years) or higher from an accredited course of study, in engineering, engineering technology, computer science, mathematics, or physics
  • Requires 3-8 years experience in a medical device or highly regulated industry
  • Experience working in a manufacturing environment preferred
  • One year of auditor experience preferred
  • Certification as a CQA; CQE or CQM and member of the ASQ is preferred
  • Knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC

Please submit your credentials in Word format by email to or call Rose Chu direct at for questions. Our technical recruiter/manager will contact the qualified candidates immediately to set up interviews.



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