Quality Engineer Medical Device

Job Description

The Quality Engineer is highly competent in the identified discipline of engineering. The mid-level position is responsible for proactively and creatively completing projects independently or in conjunction with or supervised by managers and senior engineers. Knowledgeable and experienced to provide input to and critical analysis of feedback from other engineers and technicians. Capable of leading projects independently or as part of a team. Measured against performance plan goals and objectives.

Duties and Responsibilities:

• Leads and drives the environmental monitoring and cleanroom certification program at IMI.
• Responsible for the gauge qualification program and assuring that all gauges used by IMI quality control and quality assurance can meet the precision and accuracy requirements.
• Provides oversight and input to quality processes at IMI for the purpose of continuous improvement.
• Identifies shortcomings in the QMS and leads, supports, or provides oversight for any/all improvements or changes required in the QMS.
• Provides support to the supplier quality management program, including but not limited to supplier qualification, supplier quality monitoring, tracking supplier performance, and updating/reviewing internal inspection documents for incoming material.
• Qualifies and functions as an internal auditor and/or supplier auditor as assigned.
• Provides technical support to quality investigations for nonconformances, CAPAs, customer complaints, and deviations.
• Qualifies and functions as a backup to other QA / RA activities as assigned.
  
  

Required Qualifications:

• Bachelor's degree in engineering or science.
• 5 years in a similar quality assurance program, department, or operation.
• Experience working for an organization certified to ISO 13485 or/and 21CFR Part 820.
• Proficiency in MS Office, including Word and Excel.
• Excellent communication skills, both orally and written, at all levels of an organization.
• Strong organizational skills and motivational skills.
• Demonstrated ability to solve practical problems and make logical decisions.
• Ability to work independently, as well as within a team.
• Highly motivated, high-potential individual capable of leading people in a dynamic fast-changing industrial setting.
  
  

Preferred Qualifications:

• Master’s degree in engineering or science.
• CQE, CQM, CQA, CQI, and/or CQT (ASQ-certified certifications).
• Experience with process analysis software such as Minitab or high-level Excel.
• Medical device product and/or market knowledge.
• Ability to travel domestically. Holds a valid passport or can obtain a passport to allow for international travel.
• Experience with ethylene oxide sterilization of medical devices. Gamma sterilization is weaker but a plus.
  
  

Physical/Mental Demands:

• Working conditions are normal for an office environment.
• Work may require weekend and evening work.
• Work under stress in a fast-paced environment.
• Must be alert, able to concentrate, and use good judgment.
• Must be able to work under conditions that require sitting, standing, walking.
• Must be able to sit or stand throughout most of a shift with occasional walking.
  
  

Repetitive bending, reaching, pulling, pushing, and lifting.