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Job Description
Quality Engineer sought to provide technical support to project teams and clients in a medical device environment.
Key responsibilities include:
- Providing technical quality support to project managers, design engineers, production managers, and clients
- Working closely with the engineering team and clients to establish and maintain compliant product specifications
- Quality reviewing process validation plans, protocols, and reports
- Coordinating and contributing to the generation and maintenance of compliant product risk management files
- Issuing, reviewing, and releasing lot records to manufacturing
- Coordinating and reviewing testing and release of sterilized products
- Quality reviewing SOPs, work instructions, templates, material specifications, etc. to ensure compliance with applicable regulatory standards and cGMP procedures
- Reviewing and approving product change controls
- Liaising with suppliers and clients on quality-related issues
- Maintaining, further developing, and continuously improving the QMS
- Supporting QMS as quality coordinator in investigation, root cause analysis, disposition, and corrective action of non-conformances and customer complaints
- Performing CAPA reports
- Supporting clients in product submission to applicable regulatory authorities
- Conducting internal audits and compiling associated documentation
- Supporting and assisting in the preparation for customer and surveillance audits
- Updating job knowledge by participating in educational opportunities
Requirements:
- Minimum degree in a science or engineering discipline
- At least 3-5 years of experience working in a medical device environment
- Strong knowledge of ISO 13485, FDA regulations 21CFR 820, MDR, and FDA product submission requirements
- Internal/external auditing experience is an advantage
- Validation experience, including sterilization, process, and packaging validations, is beneficial
- Knowledge of medical device manufacturing environments, including cGMP, is an advantage
- Strong understanding of the general principles of ISO 14971
- Strong decision-making ability, coupled with the ability to work independently and multitask
- Excellent written and verbal communication skills
- Excellent attention to detail and numerical problem-solving ability
- Excellent MS Office experience (Word, Excel, PowerPoint, etc.)