Senior Quality Engineer
Provides QA technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs.
- Provides Quality support/guidance to R&D and Lifecycle Management projects leads/team members.
- Resolves project issues by working with team members, suppliers, and others as appropriate Applies thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
- Manages and maintains the records related to design control applicable to product development and design/manufacturing change projects.
- Provides input into the generation of risk management file documents; Risk Management Plan, dFMECA, pFMECA and associated reports.
- Provides input into development of protocols / reports supporting the Design control process.
- Provides input and review to protocols and reports for sterilization, biocompatibility and packaging validations.
- Co-ordinates the review and approval of production records and sterilization records of product manufactured during the design control process to facilitate timely approval of Design reports.
- Supports the translation of the design requirements into manufacturing requirements.
- Ongoing monitoring of data from Quality Management systems and provision of immediate feedback to quality management on deviations or issues of concern.
- Leads and/or facilitates compliance and improvement activities associated with the Quality System (e.g. CAPA).
- Responsible for communicating business related issues or opportunities to next management level.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Minimum education of degree in a technical field is preferred.
- Minimum 5 years’ experience in the medical device industry and/or IVD/pharmaceutical, with at least three years in a position with direct responsibility for QMS processes/sub-processes.
- Demonstrated knowledge of the application of the principles, concepts and practices of design control, sterilization and Quality Assurance processes.
- Experience in preparation, participation and response to external agency inspections e.g. FDA and Notified Body Inspections