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Staff QA-RA Engineer

Company: True Digital Surgery
Location: Santa Barbara
Posted on: November 13, 2021

Job Description:

About True Digital Surgery-- -With a nearly two-decade legacy of creating cutting-edge medical devices, True Digital Surgery-- - is advancing its innovative 3D surgery digital platform through the integration of optics and robotics with augmented reality and machine learning that result in life-extending outcomes for both surgeons and patients.SUMMARYThe Staff Quality / Regulatory Engineer will have sufficient Quality and Regulatory experience to have the ability to be utilized in a variety of Quality, Regulatory, and Engineering functions. Ultimately, this role will be responsible for delivering high quality products to our customers and patients. The Staff Quality / Regulatory Engineer should also be competent / familiar with highly regulated medical device quality processes and interpreting the impact of design changes on regulatory adherence. The Staff QA/RA Engineer will need to work collaboratively with external partners, regulatory authorities, outside labs, critical and/or strategic suppliers and contract manufacturers (CMs) as well as internal stakeholders such as Program Management, Engineering, Operations, Purchasing, Customer Service and the True Digital Surgery senior management team.ESSENTIAL DUTIES AND RESPONSIBILITIESinclude the following. Other duties may be assigned.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, MDR and IEC 60601).Interface with FDA, EU authorities and other regulatory agencies as requiredMake recommendation for product RA approval strategy via literature search and candidate predicate search.Perform Risk Management, Verification/Validation, and CAPA duties as requiredManage technical files for new product development - ensure that the technical (design history files) are complete and meet all governmental regulatory requirements using checklists supplied by the governmental agencies ready for regulatory agency filing.Evaluate proposed engineering / product / manufacturing changes made to a released product and advise if there is any impact to the Technical File and/or notification of change to governmental agencies requiredCoordinate outside lab quoting, prepare and attend testing, author or contribute and review test protocols / reportsUnderstand and review test protocols / test reports submitted and issue correction requests to the author(s) as necessaryAuthor comprehensive test protocols and protocol test reports and ensure that all applicable governmental requirements are met /included in the protocol reportsUnderstand labeling, user requirements, instructions for use, indications for use documents and know how they are applied to the class device to be released for saleFacilitates and follows up on Root Cause Analysis and Action Plans for Corrective and Preventive Actions (CAR/PAR).Participate in design reviews and provide guidance as necessary.Provides ongoing support for the Quality Systems team and day to day activities to ensure department goals are achieved.Supplier and Contract Manufacturer QAContinuous Process Improvement (CPI) of TDSs Quality Management System, Processes, Work Instructions and FormsTechnical Writing to document the above essential duties and responsibilitiesWork in a team environment with external stakeholders such as partners, critical and/or strategic suppliers, labs and contract manufacturers (CMs) as well as internal stakeholders such as Engineering, QA, Regulatory Affairs, Operations, Purchasing, Customer Service and the True Digital Surgery senior management team.QUALIFICATIONSTo 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/ExperienceCandidates with a Bachelor of Science Degree in Biomedical or Quality Regulatory Engineering is strongly preferred. Equivalent medical device industry work experience of five to 10 years years related experience and/or training, or equivalent combination of education and experience would be considered.Candidates with the additional working knowledge of medical device classification (Class I, II, IIa, IIb) is a big plus. Working knowledge of design history / technical file management, V&V testing, FMEA 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 SkillsTo 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 RequirementsThe 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.Work EnvironmentThe 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 environmentTo Apply:To respond to this opportunity, please apply through this ad.For more information about us, please visit 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.vOnWuVYQ94

Keywords: True Digital Surgery, Santa Barbara , Staff QA-RA Engineer, Engineering , Santa Barbara, California

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