Quality Engineer, Medical Devices, New Product Development, ISO 13485, 14971, 62304, Software, Hardware, SDLC, Design Controls, Risk Management
As directed by the Quality Manager, the Senior Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. The Quality Engineer will be working closely with both hardware and software development teams.
- Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.
- Is a team member representing Quality on new product development and sustaining engineering projects.
- Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
- Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good manufacturing Practices (Auditor-in-Training)
- Makes measurable improvements to processes and procedures
- Contributes to the completion of specific programs and projects.
- Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and lower level project developers
- Prepares/Revises policies/procedures.
- May be expected to make presentations
- Works under general direction.
- Independently determines and develops approach to solutions.
- May provide guidance and work direction to lower level project developers
- Designs and performs development working independently within defined parameters with minimal supervision required
- Bachelors Degree, preferably in Engineering discipline
- Minimum 5 years of quality engineering experience
- Understanding of the software development (SW) and testing life cycle as defined by ISO 62304.
- Experience supporting Software related R&D design change efforts through development and/or testing.
- Understanding of software issues tracking, automation, risk assessment and bug containment.
- Experience in medical device design controls and risk management
- Validations and Verification experience
- Knowledge of medical device regulations (FDA 21CFR80.820, ISO13485)
- Experience in design for six sigma and DMAIC preferred
- Understand basic Reliability Engineering practices preferred
- Experience with injection molding preferred
Sthree US is acting as an Employment Agency in relation to this vacancy.