JOB SUMMARY The Quality Engineer is responsible for the quality assurance of product design and supplier controls / performance. He / she must understand and be able to implement the relevant requirements of the Quality System Regulation (21 CFR 820) and ISO 13485. He/she initiates and facilitates improvements to the quality system while providing technical support to R&D, Manufacturing, and Supply Chain. This position serves as a Quality representative on new product development and provides technical support and leadership of quality deliverables. Also responsible to support R&D and Operations during all product development phases and support creation of design controls as well as process qualification/validation activities, statistically sound sampling plans and process control plans including inspection/test method development and product investigations resulting from field complaints.Ensure that vendors / suppliers deliver quality products, materials, and services in accordance with specifications, purchase orders, and quality agreements. Monitor parts from purchasing through the manufacturing cycle. Communicates and resolves supplier-related problems as they occur. Assists in evaluating suppliers’ performance and provides feedback. Support activities associated with supplier quality within a medical device environment. Collaborates with Regulatory, Supply Chain, Quality, Manufacturing, Engineering, and Customer Support for compliance to all specifications. Develops, applies, and reviews procedures in accordance with 21 CFR 820 and ISO 13485. Collaborates with new & existing product development teams to ensure quality standards are met. Support and/or lead supplier quality activities such as supplier qualification, supplier audits, inspection plans, root cause analysis, CAPA investigation, and supplier performance monitoring. DUTIES & RESPONSIBILITIESFacilitate the incorporation of quality systems/regulatory requirements in accordance with FDA QSR (21 CFR: Part 820), ISO13485, European MDD / MDR, and all other applicable regulationsPromote and audit corrective actions and continuous improvement efforts for quality management systems.Promote and audit corrective actions and continuous improvement efforts for quality management systems.Provide active support for internal, third party and customer audits. This requirement includes the post audit requirements for reviewing, dispositioning, mitigating and incorporating any observations, non-conformances, opportunities for improvement and potential gaps/preventive actions. Participate in the risk management process ensuring, when applicable, that hazards are adequately mitigated in product and process quality plansAnalyze, develop and maintain key metrics for trends indicating the effectiveness and suitability of the QMS and identify areas for improvement.Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to Think Surgical productsSupport new product introduction projects through development and execution of process validation and verification test plans, protocols, and reportPlan and direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devicesCreate Quality Plans Coordinate and maintain calibration logs and activities Perform DHF/DHR review for product release. Assist the Quality Department on an as-needed basis. Other duties or MDD projects as required to meet company’s objectives QUALIFICATIONS Required:Bachelor’s degree (or equivalent experience) with 3-5 years of related experience Certified Quality Engineer a plus Certified ISO 13485 Lead Auditor a plusAble to travel up to 10 % of the time Experience with the creation of Procedures, Protocols, Test Reports, and Work InstructionsParticipate in Risk Analysis (Design/Process) meetings and action requirementsAbility to manage priorities and workflow in a rapidly changing environment Experience working in a cross-functional team environment Experience with robotics/software a plus Experience with Medical Device Manufacturing a plusExcellent organizational, problem-solving, and analytical skillsExcellent verbal & written communication skillsGood interpersonal skillsParticipate with internal quality auditsKnowledge of Good Manufacturing Practices (GMP) and applicable Quality SystemStandards Preferred:Experience with medical instrumentation and disposables, in a regulatory environment Working knowledge of basic quality systems regulations such as QSR and ISO. Proficient technical writing skills and use of documentation programs (Example Office Windows, Excel, Access, Power Point, etc.). Working knowledge of fundamental quality and statistical toolsPossess excellent interpersonal and communication skills with the ability to develop trust, respect and confidence with internal and external customers.Attendance and Punctuality are essential function of the position. COMPETENCIES Drives resultsOptimizes work processesDecision Quality PHYSICAL DEMANDS & WORK ENVIRONMENTMust be able to remain in a stationary position and operate office equipment for a prolonged period of time. Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.Occasionally work around moving mechanical parts.Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.Must be able to travel as business necessitates (up to 10%). Disclaimer:The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions.THINK Surgical, Inc. (“THINK”) is committed to hiring the best qualified candidates for approved positions while engaging in recruitment and selection practices that are in compliance with all applicable employment laws. It is the policy of THINK to provide equal employment opportunity for employment to all applicants and employees, regardless of any protected status. Any qualified applicant or employee with a disability who requires an accommodation in connection with his/her employment at THINK should contact Human Resources and request an accommodation. THINK also participates in E-Verify, a web-based system that allows THINK to confirm an employee’s eligibility to work in the United States.Actual compensation offered will depend on several factors including but not limited to geographic location, work experience, education, skill level, and/or other business and organizational needs.THINK Surgical, Inc. also participates in E-Verify, a web-based system that allows THINK to confirm an employee’s eligibility to work in the United States.