Quality Assurance Specialist

4 weeks ago


Elkton, Maryland, United States ManpowerGroup Full time

Quality Assurance Specialist

We are seeking a Quality Assurance Specialist to join our team at ManpowerGroup. As a Quality Assurance Specialist, you will be responsible for ensuring that our medical devices meet or exceed customer expectations and requirements.

Key Responsibilities:

  • Support production and project activities to drive continuous improvement.
  • Ensure compliance to quality policy, respond to customer complaints, perform audits, develop test methods, and/or write procedures for material characterization.
  • Investigate and analyze customer/internal complaints.
  • Perform data analysis and execute experiments to qualify or resolve product and process issues.
  • Develop and implement master validation plans, validation protocols, inspection plans, and quality/regulatory compliance operating procedures to meet FDA and ISO requirements.

Requirements:

  • 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.
  • Knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, 21 CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC.

About Us:

ManpowerGroup is committed to providing equal employment opportunities in a professional, high-quality work environment. We are an equal opportunity employer and welcome applications from diverse candidates.



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