Senior Quality Engineer

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 (
• Other support to QA / QC and RA staff as assigned by upper management.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education / Experience

Typically requires a minimum of 4 years of related experience with a Bachelor’s degree; or 2 years and a Master’s degree; or a PhD without experience; or equivalent work experience.

Medical device industry work experience of 6-10 years or related experience and / or training, or equivalent combination of education and experience would be considered.

Candidates with expert knowledge of ISO 13485, 21CFR820, EU Medical Device Regulation (MDR 2017 / 745), medical device classification (Class II, IIa, IIb). Working knowledge of design history / technical file management, V&V testing, PFMEA creation, risk analysis for medical devices is strongly recommended.

Candidates should be comfortable working in a high-paced environment with complex system solutions involving HW, SW, Optics, Imaging, Robotics and Navigation used in a medical device.

Computer Skills

To perform this job successfully, an individual should have knowledge of Microsoft Office including Word, Excel, Outlook; and Database software. Knowledge of the e-filing for US FDA applications for medical devices is a plus.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and / or move up to 50 pounds and frequently lift and / or move up to 20 pounds. Specific vision abilities required by this job include color, distance and close vision.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate.

Benefits :

We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment

To Apply :

To respond to this opportunity, please apply through this ad.

For more information about us, please visit www.truedigitalsurgery.com

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Salary : $110,000 - $125,000