Quality Assurance Specialist

2 weeks ago


Conshohocken, Pennsylvania, United States Extremity Care Full time
Job Title: Quality Systems Engineer

At Extremity Care, we are seeking a highly skilled Quality Systems Engineer to join our team. As a key member of our quality team, you will be responsible for ensuring the development, implementation, and monitoring of quality systems and processes that meet regulatory requirements.

Key Responsibilities:
  • Support new product development activities by participating in the development of Master Validation Plans, PFMEA's, Control Plans, and Procedure and Process development.
  • Investigate and resolve quality events, including NCs and CAPAs, and assist in other CAPA activities as directed.
  • Own applicable quality systems-related NC/CAPA's and maintain current knowledge of FDA QSR, FDA 21 CFR 1271, ISO 13485, AATB Standards, and DMEPOS requirements.
  • Analyze inspection and testing processes, mechanisms, and equipment, and develop and/or review product, process test equipment, and/or software validation and qualification protocols.
  • Ensure all environmental and product monitoring requirements are met, and create and maintain quality indicators and respective reports/presentations.
  • Develop and train quality employees, and maintain an influential and effective network and communication with leadership team members for identifying quality improvement opportunities.
  • Evaluate, implement, and continuously improve execution of quality systems and business processes, including product controls to achieve quality goals and maintain regulatory compliance.
Requirements:
  • A minimum of a bachelor's degree in science, engineering, or other relevant discipline, and a minimum of 3 years of experience working in an FDA or ISO regulated environment.
  • A minimum of 3 years of supervisory experience or equivalent.


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