Senior Quality Engineer
7 days ago
ABOUT US
True Digital Surgery is a World Leader in Computer-Guided Microsurgery. We combine 3D visualization and guidance software applications focused on improving accuracy, efficiency and outcomes for surgeons and patients. Our medical imaging and guidance system employs advanced real-time 3D graphic capabilities and proprietary software that is sold to surgeons and hospitals all over the world.
SUMMARY
The Senior Quality Engineer will have considerable Quality Management System (QMS) and Quality Engineering product experience in a medical device company. The individual will promote and foster a quality mindset throughout the organization, ensuring that there is a culture of quality, compliance and continuous improvement. The Senior Quality Engineer assures the organization, products and processes conforms to all QMS requirements including applicable standards, statutory, regulatory, customer, product and internal requirements and ensures confidence in the quality of our products. The Senior QE will need to work collaboratively with external partners, critical and/or strategic suppliers and contract manufacturers (CMs) as well as internal stakeholders such as program management, product management, engineering, operations, purchasing, customer support, technical service and the True Digital Surgery senior management team to achieve quality objectives. The Senior QE responsibilities will encompass ownership of the QMS, support for new product development, support and review of released products in production and review of design changes to existing products. The Senior QE may provide technical team leadership of up to 3-4 team members.
SALARY AND PAY TRANSPARENCY
Salary range for this position is between $110,000 and $125,000. Base pay is dependent upon many factors, such as: training, transferable skills, work experience, education, business needs and market demands. The base pay range is subject to change and may be modified in the future. This role may also be eligible for bonus, equity, and all applicable company benefits.
The salary range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Leadership, mentor, design, implementation, maintenance, audit and execution of the QMS
- Supports product development projects throughout concept to launch in all Design Control process phases from Quality Engineering perspective.
- Continuous Process Improvement (CPI) of TDS’s QMS, Processes, Templates, Work Instructions and Forms
- Lead the organizations establishment of annual Management Quality Objectives and the reporting and measurement of the established Quality Objectives
- Leads, facilitates, and owns the Material Review Board (MRB), Corrective/Preventive Actions, and Deviation throughout investigation, root cause analysis, containment and risk mitigation actions
- Completes measurement system analyses and validates test methods as needed
- Support and review of test protocols and results and issue correction requests as necessary
- Administration and technical support of internal and external audits to maintain certification to standards. Familiar with appropriate standards including but not limited to ISO 13485, FDA 21 CFR 820, MDR/UKCA and IEC 60601
- In collaboration with engineering and operations
- author production travelers
- author quality control inspection criteria (QCIC) for control of incoming material
- authoring of validation plans for new processes, tools and fixtures
- In collaboration with engineering, operations and purchasing
- manage Approved Vendor List for suppliers, vendors and contract manufacturers
- perform critical supplier audits
- manage ongoing calibration of tools and test equipment
- Participate in project teams and lead up to 3-4 team members in project execution for new product introduction
- Co-lead manufacturing process validation for internal operations and critical suppliers and/or contract manufacturers who manufacture to TDS specifications
- Documenting and maintenance of departmental Work Instructions
- Technical Writing to document the above essential duties and responsibilities
- Work professionally and collaboratively in a team environment with external and internal stakeholders
- Occasional travel may be required (
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