Staff Quality Assurance Engineer
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.
The Staff Quality Assurance (QA) Engineer will have considerable Quality Management System (QMS) and Quality Engineering product experience in a medical device company. The Staff QA Engineer’s responsibilities will encompass ownership of the QMS, QA engineering for new product development, QA of released products in production and QA of design changes to existing products. The individual will promote and foster a quality mindset throughout the organization, ensuring the organization, products and processes conforms to all QMS requirements. The Staff QA Engineer will 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Includes the following. Other duties may be assigned.
- Supports product development projects throughout concept to launch in all Design Control process phases from Quality Engineering perspective
- Understands and is familiar with appropriate standards and how to apply them to products and processes efficiently (including but not limited to ISO 13485, FDA 21 CFR 820, EU MDR 2017/745 and IEC 60601)
- Evaluates proposed engineering product and design changes for adherence to the QMS
- Responsible for the investigation, documentation, root cause, and corrective action activities of deviations and non-conforming material
- Leads, facilitates, and owns corrective and preventive actions (CAR/PAR)
- Supports and review risk management, test protocols/reports and issue correction requests as necessary
- Supports new product introduction team (NPI) on launching new product/services to production
- Oversees, evaluates, and calibrates equipment, systems, and procedures used in the development and production of products. Authoring of validation plans for new processes as needed
- Collaborates to determine acceptance activities and authors quality control inspection criteria (QCIC) and inspection plan for incoming material
- Completes measurement system analyses and validates test methods as needed
- Manages supplier’s list and perform supplier assessments, audits, and process validation for critical suppliers / contract manufacturers
- Supports all departments to ensure compliance with the QMS and lead continuous improvement efforts of the QMS (Quality Procedures, Work Instructions, and Forms). Support QMS audits (internal and external)
- Participant in Management Review (meeting and preparation) and monitor quality objective status
- Technical Writing to document the above essential duties and responsibilities
- Travel may be required (~20%)
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.
Typically requires a minimum of 7 years of related experience and/or training, or equivalent; with a Bachelor’s degree in Engineering, Biomedical, Quality Engineering or similar field of study.
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.
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.
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 10 pounds. Specific vision abilities required by this job include color, distance and close vision.
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.
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 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.