Senior Quality Engineer
Supporting operations goals for quality and reliability, continuous improvement, and problem solving. Develop, establish, and maintain quality engineering methodologies and practices, which meet BSC, customer, and regulatory requirements.
- Control manufacturing process defects by leading efforts focused on identifying primary root causes and implementing corrective and preventative actions.
- Develop and coordinate the execution and documentation of Design Validation and Verification activities to confirm design and to support regulatory submissions to Notified Bodies and FDA.
- Participate in development of product risk management tools.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Support the determination and implementation of Design controls based on Risk Management, Customer Needs and Manufacturing Input.
- Application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.
- Support the Design Control System during audit activities (DEKRA audit, Internal mock audit).
- Establish and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints) for In-House Tissue fixation.
- Supervise Quality Inspectors for manufacturing production group. Ensure inspectors are cross trained and allocate resources for inspection processes.
- Supervise Operations Quality Engineer I. Mentor and provide guidance regarding Nonconforming Reports, Material Review Board, engineering protocols/reports and trending production quality metrics.