Title: Quality Assurance Engineer
Purpose of Job:
Responsible for: Providing Quality support to processes, materials, and products. Assuring Quality standards are maintained and assist with the implementation of and compliance to the Quality Management program and for supporting company goals, objectives, policies, procedures, quality systems and compliance with regulatory requirements (ISO, FDA, JPAL and other agencies as applicable).
Duties and Responsibilities:
- Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instruction updates, and FMEA’s for any product line extensions, process improvements for new and existing products.
- Review and/or develop and execute facility, software, process and equipment validations and risk management documents.
- Review change controls for validation impact.
- Use knowledge of statistics to assist with validation developments and process improvements
- Provide quality support to Manufacturing Engineering with sampling plans, data processing or analysis for validation for new and existing product lines.
- Assist in the analysis and resolution of problems that may reduce the efficient running of production lines.
- Provide quality support to Manufacturing Engineering with NCMR and CAPA investigation, processing and disposition.
- Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
- Perform Internal Audits.
- Assist in the development, analysis, and improvement of site Quality Metrics.
- Will abide to Environmental, Health, and Safety (EHS) Policies and any relevant other EHS documentation.
- Will comply with all relevant training required and adhere to relevant associated documentation.
- Follow strict adherence to the requirements of CGMP.
- Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
- Degree in Engineering or Science or minimum of 5 years experience in a Medical Device environment.
- Five (5) years experience working in a regulated environment, specifically medical device, FDA or ISO 13485 registered work environments.
- Strong computer skills (MS Excel, PowerPoint, Word, etc)
- Familiarity with statistical tools such as Pareto charts and trend charts.
- Familiarity with FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.
- Experience with problem-solving techniques
- Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.
For more information or a confidential discussion, please contact David Lennon.