Sr. Quality Engineer

Cardinal Health•Greenwood, SC

About The Position

Quality Engineering is responsible for product and service quality planning, evaluation and control. Works cross-functionally in the development and implementation of prevention based methodologies used in design, manufacturer, test, sustainability and correction of products and services. Demonstrates understanding of quality philosophies, principles, systems, methods, tools, and standards. Demonstrates understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up. Develops and implements quality programs, including tracking, analyzing, reporting and problem solving. Plans, controls, and assures product and process quality in accordance with quality principles, which include planning processes, design control, material control, acceptance sampling and measurement systems. Demonstrates knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting. Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements. Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.

Requirements

Bachelors in related field, or equivalent work experience, preferred
2+ years’ experience in related field, preferred
Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
Works on projects of moderate scope and complexity
Identifies possible solutions to a variety of technical problems and takes actions to resolve
Applies judgment within defined parameters
Receives general guidance may receive more detailed instruction on new projects
Work reviewed for sound reasoning and accuracy

Nice To Haves

Green belt, white belt, black belt certifications a plus

Responsibilities

Observe all safety precautions and regulations at all times in all areas where duties are performed.
Responsible for reporting all safety hazards and potential unsafe working conditions.
Responsible for seeing that all tasks are performed in a manner that complies with Greenwood’s Quality System
Solid base knowledge of the Quality System Regulation (CFR 820)
Participate in applicable Quality System Standards and Regulations, FDA, supplier, customer and internal audits as required.
Conduct GMP training for all new hires as part of their orientation.
Provide refresher training as needed for all employees.
Provide quality engineering support in new product development.
Review new and modified product designs for safety, testability, reliability, serviceability, and manufacturability.
Perform product risk assessment and failure mode effects analysis (FMEA).
Create verification and validation test plans and conduct prototype testing and analysis for reliability, standards compliance, and product requirements compliance.
Perform statistical analysis of test results.
Conduct quality audits and develop subsequent preventive action programs
Support the nonconforming product and material on hold systems, including placing product on electronic hold, reviewing and revising expiration dates as necessary and facilitating Material Review Boards to determine disposition of nonconforming products.
Investigate and respond to customer complaints, including facilitating Material Review Boards to determine disposition of nonconforming product.
Determine root cause/corrective and/or preventive action for material on hold, customer complaints, externally generated Supplier Corrective Actions (SCARs) and CAPAs.
Evaluate internally generated CAPAs for root cause and effective corrective actions.
Update/revise product plans of control and other site documentation where necessary.
Maintain and evaluate sampling plans.
Process Corporate Holds.
Assist in process improvements as related to improved quality and yields.
In conjunction with R&D, Operations, OPEX, and Sales and Marketing, develop specifications and test methods to meet customer, product and internal quality requirements. This may include writing procedures to carry out requirements.
Approve change notices (CNs).