Senior Quality Engineer
- Cross-Functional Team member to support new product development, procurement, manufacturing and servicing processes representing Quality Engineering discipline.
- Completes assigned Quality Engineering tasks to schedule.
- Promotes awareness of Quality and Regulatory requirements.
- Leads or participates in the development of process and procedure development/changes.
- Applies statistical process control (SPC) methods to evaluate current processes and process changes.
- Develops new approaches to solve problems identified as part of the team.
- Assist in the implementation, compliance, and maintenance of standards (e.g., FDA, ISO13485) and OGA Quality policies and procedures.
- Trains location personnel on all aspects of the Quality System and regulatory standards.
- Serves as a mentor for the Quality team to assist in developing Quality Engineering skills.
- Applies the requirements of the Quality System to processes, products or services for the location.
- Supports the manufacturing line to address quality issues and resolution.
- Provides support to metrology and preventive maintenance programs.
- Supports validation and verification strategy for new and existing products and processes as assigned.
- Leads the development and maintenance of Master Validation Plans.
- Participates in the CAPA process as required as an assignee or project team member. Investigates escalated product complaints to root cause to ensure timely customer response and correction.
- Bachelor’s degree in Engineering discipline or equivalent.
- Eight plus year’s related experience and/or training; preferably in the medical device industry related to process/quality engineering.
- Leadership experience (i.e. People and Administrative Skills); ability to lead and manage cross-functional teams.
- Knowledge of basic mechanical testing and material properties.
- Knowledge of metrology.