International Medical Industries, Inc. · 5 hours ago
Quality Assurance Engineer
Pompano Beach, FL
Full-time
Onsite
Mid, Senior Level
5+ years expInternational Medical Industries, Inc. is seeking a Quality Assurance Engineer to ensure the quality and compliance of their medical devices. This role involves leading environmental monitoring programs, collaborating with cross-functional teams, and providing oversight for quality processes to meet regulatory requirements.
Medical DeviceHealthcareManufacturingHealth Care
Responsibilities
Lead and drive the environmental monitoring and cleanroom certification program at IMI
Read and interpret engineering drawings accurately
Demonstrate strong knowledge of manufacturing protocols and continuous improvement techniques in the medical device field
Review and approve protocols and risk management documents
Apply quality engineering principles and practices, including risk management, statistical process control, and failure mode and effects analysis
Work closely with cross-functional teams to design, develop, and implement quality control measures, ensuring that all products meet regulatory requirements and customer expectations
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
Responsible for the gauge qualification program and ensuring that all gauges used by IMI quality control and quality assurance meet precision and accuracy requirements
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
Work with suppliers to improve quality and assist, where necessary, in supplier process validations
Provide oversight and input to Quality processes at IMI for the purpose of continuous improvement
Identify shortcomings in the QMS and lead, support, or provide oversight for any/all improvements or changes required in the QMS
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
Qualify and function as an internal auditor and/or supplier auditor as assigned
Provide technical support to quality investigations for nonconformances, CAPAs, customer complaints, and deviations
Qualify and function as a backup to other QA / RA activities as assigned
Qualification
Required
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
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
Company
International Medical Industries, Inc.
IMI is the industry leader in tamper evident technologies for IV syringes, oral dispensers and other delivery systems.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
V
Virginia Mateo
Chief Financial Officer
Company data provided by crunchbase