Careers Tyber Medical is always looking for talented people to join our team. If you are interested in our careers, you can email us your resume to keep on file at Careers@tybermed.com Multiple Development Engineering Positions Open. Senior Design Engineer, Development Engineer, Principal Engineer, Manager of R&D, and VP of R&D! Please contact us at firstname.lastname@example.org for more information and job descriptions Job Title: Quality Engineer /Senior Quality Engineer The Quality Engineer or Senior Quality Engineer supports Quality Management System elements across the organization, including but not limited to the following areas: Document Control, CAPA, Control of Nonconforming Material, Quality Events, Process Validation, and more. ROLE AND RESPONSIBILITIES Primary Responsibilities 1A. Documentation Control Support continuous improvement of quality system processes and procedures, including developing and maintaining Standard Operating Procedures (SOPs). Support other QMS areas as needed, including but not limited to: internal and external audit support; training development and management; CAPA investigations, corrective actions, and effectiveness checks. Coordinate development and change control activities, product quality plans, inspection forms (FAI, in process, and final QC), methods of manufacturing, item master, inspection rules, and other documents as needed. Support process validation activities. Support supplier onboarding activities. Support dose audit activities. Secondary Responsibilities Support manufacturing site inspections and audits as needed. Support complaint and nonconforming product investigations as needed. Perform internal and supplier audits as needed. REQUIREMENTS Bachelor’s Degree in Engineering or Related Science field preferred Relevant work experience in the FDA QSR/ISO 13485 medical device industry. Some knowledge of GMP Manufacturing and Standards and Regulations, including but not limited to ISO 13485, ISO 14971, and QSR. PREFERRED SKILLS Excellent organizational and computer skills Demonstrated ability to analyze and interpret information Familiarity with engineering drawings Familiarity with process validation (IQ, OQ, PQ) Familiarity with risk management concepts Basic understanding of inspection and test equipment Strong problem-solving skills Title: Quality Technician General Position Description The Quality Technician organizes and runs the routine analysis of the Quality Control Department. This job is essential in ensuring the Quality Control Department meets its goals of efficiency and customer satisfaction. This individual is responsible for conducting inspection and testing procedures during manufacturing processes and receiving inspection processes to ensure the products comply with requirements. Key Responsibilities and Accountabilities Develop and maintain inspection reports. Develop and run CMM / Vision system programs. Performs Gage R&R and MSA as required. Ability to use foresight to anticipate department needs such as gages and other supplies. Assist with Special Projects as directed by Manager. Ensure compliance to federal and state laws, as well as company standards and specifications. Perform inspections across all stages of production. Share process improvement ideas with the Manager. Perform and follow standard operating procedures Assist in training employees on procedures, use of equipment, production techniques and method development as demonstrated by the Manager. Prepare and maintain test data for review. Evaluate data and draft reports, noting any relevant deviations from existing standards. Maintain flow of QC samples and delegate necessary tasks to ensure deadlines are met Coordinate and support first article inspection and validation activities. Manage program to evaluate precision and accuracy of test, measurement, and analytical equipment. Assist in training others in programming of all vision systems and CMM Maintain and implement methods and procedures for the disposition of discrepant material. Select and pursue continuous improvement projects to improve the current quality or efficiency of the QC process, such as in a Lean Six Sigma experiment. Communicate quality or compliance with urgency. Responsible for preventative maintenance activities. Other Duties as assigned. Work Experience Requirements and Skills ASQ certification and at least five-year experience in the quality control department or manufacturing. Ability to ensure organization and prioritization in order to meet production goals and deadlines Excellent written and verbal communication skills and attention to detail Ability to problem solve and maintain critical thinking Sound understanding of the concepts and principle of inspection techniques and methods. Knowledge and understanding of geometric dimensioning and tolerance. Ability to interpret engineering drawings and handle various types of measuring instruments such as micrometers, calipers, optical comparators and vision system measuring machines. Ability to prioritize, multi-task and complete essential responsibilities with minimal oversight. Highly motivated to initiate projects and drive to execute through completion Data Analysis, report writing, and business correspondence Computer skills – Word, Excel, Power Point, knowledge of basic ERP systems Knowledge of FDA Good Manufacturing Practices (cGMP’s) and general understanding of Quality System Regulations and International QMS standards (ISO) GD&T SUPERVISORY RESPONSIBILITIES There are no supervisory responsibilities for this position. QUALIFICATIONS Knowledge of human resource functions including business management and strategy, workforce planning and employment, benefits, human resources development, employee relations and risk management Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources Excellent interpersonal skills, team-oriented and ability to deal with a wide variety of personalities, communication and learning styles Ability to work independently, set goals, prioritize, organize and accomplish work timely Ability to work in a team environment requiring collaboration Ability to define problems, collect data, establish facts, and draw valid conclusions Superior ability to work effectively with changing priorities in an ambiguous environment Strong ability to work in a fast-paced environment Accepting of criticism and ability to deal calmly and effectively with stressful situations Excellent communication skills, verbal and written Excellent attention to detail Highly developed organizational skills Excellent presentation skills High degree of professionalism Ability to support off shifts (occasionally) EDUCATION/EXPERIENCE Bachelor’s degree from a four-year college or university in a related field of study and one year related experience; or Associates degree from a two-year college or university in a related field of study with two or more years related experience and/or training; or equivalent combination of education and experience.