Quality Engineer

Responsibilities

• Work cooperatively with other team members and in compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 to transition products from development to manufacturing
• Use experience within medical devices, to provide guidance and assistance in the development of new production processes
• Drive the development, implementation, and approval of PFMEAs and control plans
• Develop inspection processes and sampling plans according to the risk level of the components, material and devices
• Ensure all product, processes, and components are within specifications and work with internal team and with customers to resolve any nonconformance issues
• Facilitate the development, implementation, and approval of Device Master Records and Device History Records
• Review existing procedures and for continuous improvement and improved workflow
• Lead investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills
• Use critical thinking and deductive reasoning to make risk based decisions
• Develop and approve technical documents to plan work, such as Master Validation Plans, Quality Plans, and Qualification Protocols; support execution of work product
• Collect and evaluate data, lead system and process improvements using six sigma tools
• Provide reliability and statistical analysis of data for investigations, qualifications, test method validations and other Quality related activities
• Participate in ISO 13485 audits and assist in FDA and other regulatory inspections
• Will use Microsoft Office software (Word, Outlook, Excel)

Qualifications and Skills

• 3 + years of experience in occupation related to Quality Control of medical devices
• Experience with compliance, with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 is required
• Experience participating in internal and external audits

Education

Bachelor’s degree or equivalent experience in Industrial, Mechanical or related engineering / life sciences related discipline.