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Quality Engineer

Location:Morrisville, NC
Benefits:Comprehensive Benefits Package including 401K
Employment Type:Full Time
Description:The quality engineer will be responsible for supporting new product development with design controls, supplier selection, validations, participating in drawing reviews and reviewing tolerance stacks. This position will also support existing products through corrective actions, supplier audits and resolving issues with non-conforming products.

Promote team environment and continuous improvement. Project a positive and supportive approach to staff and other departments in related areas. Provide support to manufacturing and production staff to achieve company and quality related objectives. Interact with all levels of the company to provide status and updates of projects.
Duties:1.1. QA representative for design control/product realization activities including but not limited to classification of quality characteristics, design inputs and review, technical drawings and specifications, design verification and reliability and maintainability.
2. Implement and manage product quality programs, including part qualification, inspection and test methodologies, supplier qualification, developing and maintaining the quality plans, leading or performing gage studies, etc.
3. Lead quality assurance tasks in development and manufacturing to ensure processes are capable and quality tools and systems are in place to launch new products. Provide input into IQ/OQ/PQ validation plans and protocols as necessary.
4. Exercises statistical judgment in selecting methods, techniques and evaluation criteria for obtaining results.
5. Supports change control for existing products through review & approval of engineering reports, drawing changes, supplier evaluations, review of biocompatibility and bioburden analysis and design change paperwork.
6. Defines, selects, and applies various techniques including supplier qualification, certification, evaluation, ratings, performance improvements, etc for development and selection of suppliers during the product development process.
7. Define, describe, and use various deployment tools in support of the Quality System in accordance with cGMP and ISO standards.
8. Develops, applies, revises and maintains quality standards for processing materials into partially finished or finished products.
9. Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
10. Identify and apply Cost of Quality (COQ) concepts, including cost categories, data collection methods and classification, reporting and interpreting results.
11. Analyzes product quality performance data to identify high priority issues relating to safety and customer dissatisfaction.
12. Leads investigative teams to determine root causes of quality issues related to design and manufacturing
13. Investigate, document and implement corrective actions as needed.
14. Use electronic data systems such as Agile PLM, UniPoint and SysPro.
15. All Other Essential Duties as directed.

2+ years in a quality engineering role, preferably in the medical device or pharmaceutical industry
BS /MS in Engineering


Strong statistics background and is data driven.
Experience working with mechanical drawings and GD&T.
Experience performing audits.
Exposure to material selection criteria
Exposure to Validations in Medical Device environment would be a plus
Experience with Electro Mechanical or Optical systems would be a plus


Must be able to lift at least 25 lbs.

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