Summary of Role
Responsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control operations. Working with internal and external customers supports, quality and continuous improvement using appropriate tools, project leadership.
Quality Engineer Expectations:
- Supports internal audit program as necessary.
- Supports customer complaint (CC) and RMA system per procedures. Performs investigations, supports determination of the disposition of returned goods, determines re-inspection requirements, determines corrective and preventive actions (CAPA), issues complaint reports, supports completion of customer CAPAs, and approves to close. Looks for trends to determine actions to decrease number of CCs
- Maintains Non-Conforming (NC) system per procedures. Performs investigations, participates in MRB (Material Review Board) activities, supports determination of the disposition, determines re-inspection requirement, supports determination of corrections/corrective actions and approves to close. Looks for trends to decrease number of NCs and provide feedback to management
- Maintains corrective and preventive action (CAPA) system per procedures. Initiates and performs root cause analysis. Uses statistical and capability analysis to solve problems. Implements and verifies CAPAs
- Performs trend analysis of CAPA, NCM, Complaint/Customer Feedback, Risk Management activities, Audits, etc. and presents periodic reports for management review. Assesses Design and any associated activities for manufacturability.
- Adheres to the company’s Quality System (QS), writes and approves QS documents
- Authors and executes Quality Plans for Quality Management Systems and Organizational Objectives projects.
- Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product quality.
- Communicates with customers on complaints, process changes, clarification of specifications, completing customer documents, and other projects as needed
- Conducts studies including Gauge R&R’s to develop inspection methods and test equipment. Creates measurement system programs, when necessary.
- Establishes inspections and sampling procedures to ensure the control of quality at the most economical costs
- Creates, reviews and approves Equipment Qualifications, Process, Cleaning, and Software Validation, pFMEA and other documentation as necessary.
- Participates in customer and ISO audits.
Quality Engineer Qualifications:
- 4 year degree in quality, engineering or any related field
- 2+ years in a manufacturing environment in a technical support role
- ASQ Certified Quality Engineer
- Formal Six Sigma Yellow/ Green belt training
- Ability to read, write, speak and understand the English language
- Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
- Ability to demonstrate adequate job knowledge to deliver a world class performance
- Ability to challenge oneself to consistently meet all goals and deadlines
- Willingness to strive for excellence by producing work that is free of errors and mistakes
- Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
- Commitment to making improvements company wide
- Demonstrated competence using Microsoft Office, Project, Access and JMP
- Comprehensive understanding of applicable Work Instructions, SOP’S, and ISO standards
- Working knowledge of statistical methods associated with six sigma and quality control.
- Able to perform math functions
- Effective project leader
- Experience with lean manufacturing principles and their implementation
- Good hand/eye coordination and depth perception
- Good manual dexterity
- Correctable normal reading distance vision
Last Date of Application is 05/01/2023
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