Quality Engineer

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Job Type: Full-time

• 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.

• 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 21
  
  CFR 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.

• 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.

• 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.