Quality Engineer - Medical Device

Job Description

The Engineer, Quality Assurance plays a pivotal role in ensuring the quality and compliance of our products. This mid-level position requires a high level of competence in engineering and the ability to complete projects both independently and collaboratively. The Engineer will provide critical analysis and feedback to other engineers and technicians, and lead projects either independently or as part of a team. Performance will be measured against established goals and objectives, contributing to the overall success of the organization.

Duties and Responsibilities:

As a key member of IMI’s quality team, the Engineer, Quality Assurance will play a crucial role in ensuring the compliance of our medical devices with regulatory requirements. Primary duties and responsibilities include:

• Environmental Monitoring and Cleanroom Certification: Lead and drive the environmental monitoring and cleanroom certification program at IMI.
• Engineering Drawings: Read and interpret engineering drawings accurately.
• Manufacturing Protocols and Continuous Improvement: Demonstrate strong knowledge of manufacturing protocols and continuous improvement techniques in the medical device field.
• Protocols and Risk Management: Review and approve protocols and risk management documents.
• Quality Engineering Principles: Apply quality engineering principles and practices, including risk management, statistical process control, and failure mode and effects analysis.
• Cross-Functional Collaboration: Work closely with cross-functional teams to design, develop, and implement quality control measures, ensuring that all products meet regulatory requirements and customer expectations.
• QMS Documents: Assist with the creation and revision of QMS documents (including but not limited to Standard Operating Procedures, Work Instructions) in accordance with internal requirements and industry best practices.
• Gauge Qualification Program: Responsible for the gauge qualification program and ensuring that all gauges used by IMI quality control and quality assurance meet precision and accuracy requirements.
• Test Method Validation: Carry out all aspects of Test Method Validation, including creating test/measurement methods, executing statistical analysis of test method results, authoring and executing test method validation protocols and reports in accordance with established procedures.
• Supplier Quality Improvement: Work with suppliers to improve quality and assist, where necessary, in supplier process validations.
• Quality Processes Oversight: Provide oversight and input to Quality processes at IMI for the purpose of continuous improvement.
• QMS Improvements: Identify shortcomings in the QMS and lead, support, or provide oversight for any/all improvements or changes required in the QMS.
• Supplier Quality Management: Provide 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.
• Internal and Supplier Audits: Qualify and function as an internal auditor and/or supplier auditor as assigned.
• Quality Investigations: Provide technical support to quality investigations for nonconformances, CAPAs, customer complaints, and deviations.
• Backup Support: Qualify and function as a backup to other QA / RA activities as assigned.
  
  

Required Qualifications:

• Bachelor’s degree in engineering required or CQE, CQM, CQA, CQI, and/or CQT (ASQ-certified certifications).
• 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:

• 2 years’ experience in a Quality Control or Quality Assurance position in a Medical Device Company preferred.
• Master’s degree in engineering or science.
• 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:

• Physical activity includes walking, standing, bending, squatting, reaching above shoulders, and lifting to 40 lbs.
• Performs primarily office activities in a lighted and ventilated area. May be subject to changes in temperature and exposure to dust.
• Will work in a normally acceptable office environment, production floor, or warehouse, with no abnormal hazards or risks.

Job Description

The Engineer, Quality Assurance plays a pivotal role in ensuring the quality and compliance of our products. This mid-level position requires a high level of competence in engineering and the ability to complete projects both independently and collaboratively. The Engineer will provide critical analysis and feedback to other engineers and technicians, and lead projects either independently or as part of a team. Performance will be measured against established goals and objectives, contributing to the overall success of the organization.

Duties and Responsibilities:

As a key member of IMI’s quality team, the Engineer, Quality Assurance will play a crucial role in ensuring the compliance of our medical devices with regulatory requirements. Primary duties and responsibilities include:

• Environmental Monitoring and Cleanroom Certification: Lead and drive the environmental monitoring and cleanroom certification program at IMI.
• Engineering Drawings: Read and interpret engineering drawings accurately.
• Manufacturing Protocols and Continuous Improvement: Demonstrate strong knowledge of manufacturing protocols and continuous improvement techniques in the medical device field.
• Protocols and Risk Management: Review and approve protocols and risk management documents.
• Quality Engineering Principles: Apply quality engineering principles and practices, including risk management, statistical process control, and failure mode and effects analysis.
• Cross-Functional Collaboration: Work closely with cross-functional teams to design, develop, and implement quality control measures, ensuring that all products meet regulatory requirements and customer expectations.
• QMS Documents: Assist with the creation and revision of QMS documents (including but not limited to Standard Operating Procedures, Work Instructions) in accordance with internal requirements and industry best practices.
• Gauge Qualification Program: Responsible for the gauge qualification program and ensuring that all gauges used by IMI quality control and quality assurance meet precision and accuracy requirements.
• Test Method Validation: Carry out all aspects of Test Method Validation, including creating test/measurement methods, executing statistical analysis of test method results, authoring and executing test method validation protocols and reports in accordance with established procedures.
• Supplier Quality Improvement: Work with suppliers to improve quality and assist, where necessary, in supplier process validations.
• Quality Processes Oversight: Provide oversight and input to Quality processes at IMI for the purpose of continuous improvement.
• QMS Improvements: Identify shortcomings in the QMS and lead, support, or provide oversight for any/all improvements or changes required in the QMS.
• Supplier Quality Management: Provide 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.
• Internal and Supplier Audits: Qualify and function as an internal auditor and/or supplier auditor as assigned.
• Quality Investigations: Provide technical support to quality investigations for nonconformances, CAPAs, customer complaints, and deviations.
• Backup Support: Qualify and function as a backup to other QA / RA activities as assigned.
  
  

Required Qualifications:

• Bachelor’s degree in engineering required or CQE, CQM, CQA, CQI, and/or CQT (ASQ-certified certifications).
• 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:

• 2 years’ experience in a Quality Control or Quality Assurance position in a Medical Device Company preferred.
• Master’s degree in engineering or science.
• 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:

• Physical activity includes walking, standing, bending, squatting, reaching above shoulders, and lifting to 40 lbs.
• Performs primarily office activities in a lighted and ventilated area. May be subject to changes in temperature and exposure to dust.
• Will work in a normally acceptable office environment, production floor, or warehouse, with no abnormal hazards or risks.