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Über
The IQA Inspector role supports manufacturing quality assurance activities of Argentum Medical. This position tests and inspects products at various stages of production process and maintain quality and reliability of products. Essential Functions (ACCOUNTABILITIES/RESPONSIBILITIES): Perform required inspection and testing of incoming product according to quality control plan Perform first article inspection and testing for Engineering Perform in-process and pouch seal inspection according to quality control plan Perform first article label inspection for finished product Provide final inspection on over label work order Provide assistance in the overall implementation and administration of Company policies and procedures Document and maintain accurate records of inspection and calibration results Communicate with appropriate Quality, Operations and Engineering personnel to ensure product and customer requirements are continually met Clearly document non-conformities and communicate issues to Quality and engineering personnel Assist with the Material Review Board process for the disposition of material, parts and finished product Control non-conforming material, parts and product in accordance with documented procedure Maintain QA Hold Area up to date Maintain Incoming Quality Inspection, SCAR, DHR records up to date Process owner for CAPA and SCAR process - Trending, tracking, ensuring deadline, Monitoring overall program Coordinate with Supplier for SCAR, Complaint or on open other investigation Assist with the development of inspection requirements and techniques Ensure calibration and maintenance is performed on inspection equipment Read and interpret inspection data from outside sources Participate in Quality audits to verify compliance with documented procedures and regulatory requirements Implement process controls by promoting and following all safety and quality system procedures as well as Company policies Conduct or assist with supplier auditing Conduct particulate counts in Environmentally Controlled Room in accordance with documented procedure Any other duties or responsibilities required or assigned by Director or Associate Director of Regulatory Affairs and Quality Assurance Qualifications: Experience: Five (5) year minimum work experience in a manufacturing environment Education: Associate Degree of Quality Assurance (or Technical Field) or equivalent work experience in a Quality Assurance/Control position. General Skills/Competencies/Specialized Knowledge: Communication Communicates effectively at all levels of the organization. Interpersonal Skills Ability to work with co-workers and customers, both internal and external, of all levels. Presentation Skills Demonstrated ability to present 1:1 or in group settings. Initiative Ability to work well independently and exercise appropriate judgement under general direction. Problem Solving Uses logic to solve problems. Decision Making Makes timely, sound decisions based on analysis wisdom, experience and judgement. Adaptability Embraces and adapts to change and demonstrates a willingness to learn. Trust and Integrity Interacts with others in a way that gives them confidence in one's intentions and those of the organization. Collaboration and Teamwork Works collaboratively and cooperatively with many teams cross-functionally. Customer Orientation Demonstrates a keen understanding of various customers' (internal or external) needs and utilizes a variety of internal resources to provide solutions and a compelling value proposition. Project Management Ability to plan, organize and manage resources to bring about the successful completion of specific project goals and objectives. Analytical Skills Strong analytical skills. Computer Skills Proficient computer system-based tools including Microsoft Office applications, presentation, e-mail, web browsers and spreadsheet software. Able to read and understand Work Instructions Conduct inspections using calipers, micrometers, custom gauging, optical comparators, gauge pins, gauge blocks and other technical measuring devices Working knowledge of geometric dimensioning and tolerance Proficient with mechanical drawing Not Required but Preferred: Working knowledge of ISO 13485 and FDA requirements Knowledge of Statistical Method ASQ CQI or CQT Certification TRAVEL REQUIREMENTS/WORK ENVIRONMENT and PHYSICAL DEMANDS: Travel: Must be able to travel up to 10% of the time. Work Environment and Physical Demands: 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. Specific vision abilities required by this job include Close vision.
Sprachkenntnisse
- English
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