Quality Engineer

2 weeks ago

New York, United States CivicMinds, Inc Full time

Summary: Responsible for designing, installing, and performing risk assessments of quality process systems and statistical techniques internal to the company as well as suppliers. Formulates quality policies, procedures and work instructions. Works with customers for First Article Approval. Proactively work and communicate with all departments in the area of quality with the goal of Continuous Improvement. This position supports the Engineering and Operations job functions of Quality Assurance to meet organizational objectives.

Primary Duties and Responsibilities: Develops, writes, and executes installation, operation and performance qualification protocols for equipment and systems. Devise and implement various methods and procedures for inspection, testing, and evaluating the precision, reliability, and accuracy of products and processes. Designs, installs, and evaluates quality process sampling systems, procedures, and statistical techniques. Proactively work on continuous improvement of the quality system through monitoring of production operations, personnel management, and adherence to and administration of ISO 13485 and FDA, Title 21 Part 820, QSR. Work with other departments to determine the root cause and determine CAPAs to problems involved with product quality. Analyze production and service limitations and standards. Formulates or helps formulate quality policies, procedures, and work instructions. Works with customers, suppliers, and engineers for First Article Approval and to resolve quality issues as required. Assist in quality audits including, but not limited to, FDA, Customer Audits, Supplier Audits, and Internal Audits. Serve as a Quality technical resource for requirements, risk analysis, process validation, statistical analysis, design transfer, etc. Issues and reviews supplier correction actions, to prevent any problem trends from occurring. Other duties and functions may be assigned as required.

Secondary Duties and Responsibilities: Reviews ECOs (Engineering Change Orders), requesting or authorizing changes as needed. Acts as a leader within the organization demonstrating the company’s core values and effectively implementing the Company’s strategy. Coordinates documentation of process using ISO format. Take necessary action required to remedy product quality problems; such as quarantining products or shutting down production, etc. Work together with members of the management team to manage the overall direction of the company. Must complete a Non-Compete Agreement and Patent Agreement.

Qualification: EDUCATION AND/OR EXPERIENCE: Bachelor’s degree in Engineering, Manufacturing, Mathematics or Business. In place of a degree, relevant years of work experience may suffice. 0-3 years' experience working within quality engineering systems. Experience working with, or knowledge of, business management systems particularly ISO 13485 preferred, and FDA Title 21 Part 820, QSR. ASQ Quality Engineer Certified within one (1) year as requested. Experience in or knowledge of SPC and Statistical Analysis. Computer skills in MS Office and Data Analysis Software to calculate statistics (such as Excel, Mini-Tab, etc.). Self-motivated analytical data-driven decision maker with strong leadership skills. Strong commitment to quality and customer service. Demonstrated problem-solving skills required. LEADERSHIP ABILITY: Able to lead and influence other employees in the areas of work performance, work quality, dependability, and company loyalty. Strong organizational abilities. Must be able to pass a background check REASONING ABILITY: Able to solve practical problems with a variety of variables in situations where only limited standardization exists. Able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. LANGUAGE/COMMUNICATION SKILLS: Able to read, analyze, and interpret user guides, general business periodicals, reports, technical procedures, and/or government regulations. Able to write reports, business correspondence, as well as internal procedures and instructions. Strong written and verbal communication skills. Able to effectively present information and respond to questions from customers, managers, and employees.

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