Quality Assurance Specialist at EKF Diagnostics

Boerne, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Jan, 26

Salary

0.0

Posted On

22 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Good Manufacturing Practices, Validation, Document Control, Supplier Quality Management, Training, Corrective Actions, Regulatory Compliance, ISO Standards, Analytical Skills, Communication Skills, Project Management, Problem Solving, Attention to Detail, Team Collaboration, Process Improvement

Industry

Medical Equipment Manufacturing

Description

Description The Quality Assurance Specialist is responsible for assuring the quality of manufactured products and processes in accordance with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs). The position will be primarily focused on supporting cross functional teams with quality events such as CAPA, NCR, Deviations, as well as other QMS duties outlined below. Ensures all products manufactured and services provided by the company meet the applicable quality requirements. Essential Functions, included but not limited to: Serve as Subject Matter Expert for Validation, including but not limited to; overseeing the validation master plan, schedule, and execution of equipment, process, and software validations (production and QMS) to ensure regulatory compliance. Lead validation lifecycle documentation, including protocols, reports, risk assessments ensuring traceability, compliance and effectiveness Supporting an executing quality task associated with the production floor. Support the administration of the Supplier Quality Management process. Support the Supplier program to include the selection, evaluation, and ultimate approval of new suppliers. Monitor the performance of suppliers. Conduct training in current Good Manufacturing Practice (cGMP), International Organization for Standardization (ISO) standards. Regulate document control systems including labels, IFU revisions, operating procedures, etc., and all related documents that create the Quality Management System, meeting ISO, GMP/QSR, and company directives. Write and update standard operating procedures (SOPs). Oversee the upkeep of the training program database. Coordinate Corrective and Preventative Actions (CAPAs) and non-conformance activities. Interact with all company personnel in coordination of quality and regulatory activities and sound business practices in compliance with Quality Policy and Directives. Adhere to current Good Manufacturing Practices(cGMP). Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc. Other Functions: Ensure compliance with safety regulations and procedures are implemented and followed; Maintain clean and safe work area. Assist as needed in other areas of the Company where training requirements have been completed. Perform other duties as assigned. Supervisory Responsibilities: This role has no supervisory responsibilities. Travel None. Requirements Bachelor's degree (B.A. /B.S.) from an accredited college or university in a science related field. Legally authorized to work in the United States. Three (3) years of quality experience in relation to medical devices or In vitro diagnostics devices. Strong knowledge of various standards and regulations such as ISO 9001, ISO 13485, ISO 14971, the Quality System Regulation (21 CFR Part 820), Preferred Qualifications: Five (5) years proven quality experience in relation to In vitro diagnostics devices. Knowledgeable with calibration, and supplier programs. Prior manufacturing experience. Knowledge of MDSAP Basic Skills and Abilities: Good computer skills including Microsoft Word, Excel, Outlook. Detail oriented with a high level of accuracy, efficiency, and accountability. Excellent organizational skills to meet goals and set priorities. Proven ability to handle multiple projects and meet deadlines; work in a fast-paced environment. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm. Initiative to offer new innovative ideas and improve processes. Ability to work independently and as a member of various teams and committees. Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude. Reasoning Abilities: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Must have strong analytical and planning skills sufficient to determine resources and time required to complete projects. Language Skills: Good written and oral communication skills; with the ability to interface well with management, internal employees, FDA, notified bodies, and other international regulatory authorities. Ability to read, analyze, and interpret general business periodicals, professional scientific and technical journals, technical procedures, financial reports, legal documents, and governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Mathematical Skills: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Visual Acuity: Close visual acuity to perform an activity such as preparing and analyzing data, transcribing, viewing a computer terminal, and reading. Physical Demand: Must be able to wear and work in personnel protective equipment (PPE) as required. Light physical activity performing non-strenuous daily activities of a primarily administrative nature. Stationary position sitting for prolonged periods of time while utilizing standard office tools. Constant repetitive motions that may include the wrists, hands and/or fingers to operate keyboard and mouse; dexterity and coordination necessary to handle files and single pieces of paper. The ability to hear, understand, and distinguish speech. Frequently communicate information and ideas with others to exchange information and understanding. Able to exchange accurate information in these situations. Frequently lift and/or move up to 10 pounds, occasionally lift and/or move up to 25 pounds, and rarely lift and/or move up to 50 pounds. Often move about inside the facility to access office machinery, correspond with other departments, attend meetings/training, etc. Occasionally reaching for items above and below desk level. Occasionally required to climb or balance; squat, stoop, kneel, crouch, or crawl, and smell. Environmental Conditions: Well lit, heated/air-conditioned indoor office setting with adequate ventilation. The noise level in the work environment is low. Periodic exposure to low temperatures in controlled refrigerators and/or freezers. Some exposure to hazards or physical risks which require following basic safety precaution.

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Responsibilities

The Quality Assurance Specialist ensures that manufactured products and processes meet quality standards in compliance with SOPs and GMPs. This role involves supporting cross-functional teams with quality events and overseeing validation documentation and supplier quality management.