Broad, hands on Quality Engineer role at an innovative company with game changing implantable devices and related surgical tools. In this key role you’d provide quality support for development and manufacturing. The scope includes the design, development, implementation, and improvement of R&D, production and quality processes for components and product systems. This position requires leadership skills and a willingness and ability to contribute to Quality objectives and achievement of company goals.
Take a lead role in the follow activities:
- Review, evaluate, and investigate product complaint files for all customer complaints, according to FDA and International regulatory compliance requirements.
- Manage and support all phases of the CAPA process including investigations, root cause analysis, development and implementation of corrective actions, and effectiveness monitoring.
- Conduct failure investigations and implement corrective and preventive actions.
- Coordinate the calibration and maintenance of measurement and test tools and equipment.
- Evaluation and monitoring of suppliers, as well as maintaining the Approved Supplier List.
- Evaluate and support the disposition of Nonconforming Material (MRB).
- Maintain documentation such as quality and inspection procedures and mechanical drawings.
- Ensure compliance with FDA, MDD, and other requirements in all activities.
- Participate in internal and external audits.
- Participate in supplier qualification/development activities.
- Trend monitoring
Play a support role in the following activities:
- Develop, document and implement validation and verification activities related to product and process.
- Analyze, identify and implement manufacturing process improvements to improve capability and performance as required.
- Develop and document inspection and acceptance activities including necessary fixtures.
- Participate in new product design and development activities to ensure compliance with design control requirements.
- 5 + years minimum medical device Quality Management Systems (QMS) and engineering experience.
- Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial etc.) or equivalent.
- Knowledge of FDA QSR, MDD and ISO 9000 regulations.
- General knowledge of design control requirements.
- Ability to handle multiple tasks while maintaining attention to detail and accuracy, working under tight time deadlines.
- Class 10,00 clean room experience is preferred.
- Experience with ERP/MRP systems usage and implementation preferred.