The Staff Quality Engineer is responsible for Quality Assurance and Quality Engineering activities throughout Quality Management System and Software Lifecycle. This includes ensuring that the quality management system and software lifecycle processes are compliant with applicable standards, regulations and guidance documents for medical devices and GxP computerized systems. The ability to effectively communicate applicable regulations, optimize the quality management process, and ensure ambiguities and conflicting requirements are resolved are critical to the success of the position.
- Ensures conformance of product and/or software life-cycle to applicable quality regulations and standards.
- Guides and facilitates project teams in execution of software life-cycle activities.
- Drives product and/or software risk management activities in accordance with industry standards.
- Plans and performs quality audits and assessments of design history files.
- Leads by example and mentors junior engineers.
- Must have strong technical writing and communication skills.
- Provides support to product development and project teams in the areas of quality management system, design control, risk management, verification and validation activities, information security, and data privacy.
- Supports 3P510(K) program (FDA 510(k) Third Party Review Program).
- Participates in project core teams as the Quality representative throughout the product lifecycle.
- Supports project teams during internal and external customer and quality audits
- Participates in process improvement opportunities.
- Applies applicable regulations and standards to manage the risk and provide solutions/ strategy.
- Develops and assists with updates of standard operating procedures and other Quality documents.
- Provides management with status updates on assigned responsibilities, goals and escalate issues in a timely fashion.
- Extensive knowledge of product, and specifically software life-cycle processes
- Extensive knowledge of a quality management system
- Experience and working knowledge of FDA 21 CFR Part 820 Quality System Regulation and ISO 13485 standard
- Experience and working knowledge of IEC 62304 and ISO 14971
- Experience and working knowledge of quality audits
- Experience with enterprise quality system tools (e.g., electronic CAPA, Complaint Management systems)
- Working knowledge of statistical principals and sampling plans
- Stable and fast internet connection.
- Intellectual curiosity and a drive to learn and grow
- Motivated self-starter
- Detail oriented and organized
- Skilled in written and verbal communication
- Influencing and negotiation skills preferred
- Highly responsive
Education and Experience
- 10+ years’ experience in medical device quality engineering and medical device software quality engineering
- Bachelor’s degree in Engineering, Science, or Technical field
- CSQE and / or CQA certification
- Experience working in FDA regulated environment.
- Strong knowledge of scientific principles and concepts.