Quality Assurance Engineer

QUALITY ASSURANCE ENGINEER

Summary

The Quality Assurance Engineer will be responsible for implementation and maintenance of the Quality Management System in accordance with FDA Quality System Regulations and ISO 13485. Apply engineering, technical skills and statistical techniques to make recommendations and carry out quality improvements while maintaining regulatory compliance. Work closely with Operations team to manage supplier quality program. Responsible for providing direct support and oversight of receiving inspection activities, returned material, complaint investigations, and internal corrective actions.

Responsibilities

1. Provide technical and regulatory guidance to employees regarding sterile and non-sterile medical device regulations and requirements.

2. Develop and maintain Quality Management System procedures and provide training to employees.

3. Review and authorize documentation changes to engineering prints, Quality plans, work instructions, process sheets, risk assessments and inspection plans.

4. Problem-solve using statistical and analytical techniques.

5. Implement Statistical Process Control as appropriate and provide training as necessary.

6. Represent Quality and perform as an active member of product design and development teams, assisting in product qualification, validations, and risk management.

7. Review and maintain Design History Files and Technical Files for accuracy and compliance to U.S. and global regulatory requirements.

8. Develop and maintain procedures and perform tasks as necessary including design of experiments (DOEs), process validations, equipment, and material qualifications.

9. Establish and maintain comprehensive Supplier Quality Management program including supplier qualifications, on site audits, audit schedule, quality agreements, performance monitoring, corrective actions and pursue continuous process and yield improvements.

10. Establish and maintain Product Quality and Inspection Program, including managing third party inspection providers and oversee supplier product inspection and quality plans to ensure a high level of quality and regulatory compliance..

11. Chair Material Review Board (MRB) including authorizing product disposition and providing regulatory review for nonconforming product.

12. Define and maintain Quality metrics for internal and external reporting. Perform trend analysis as required.

13. Manage the Corrective Action Preventive Action (CAPA) program by coordinating investigations with Operations, delegating tasks and actions items to other departments, as appropriate, and working closely with suppliers and internal process owners to ensure appropriate corrective and preventive action is implemented in a timely manner.

14. Lead product failure investigations and risk analysis activities, as required.

15. Coordinate and participate in internal and external audits conducted by notified bodies, government agencies, customers, or others, as required. Acts as the point of contact and liaison between the company and the respective Notified Body or third party auditor for any follow up or corrective actions, as needed.

16. Provide analysis of internal Quality issues and provides recommendations for improvements.

17. Provide guidance to Operations and Quality on Social Accountability (aka Labor Standards Assurance System) requirements, including conducting training, acting as point of contact with third party auditors, participating in on site audits, and facilitating supplier audits.

18. Support Ansell’s Quality culture by initiating and fostering a spirit of “Quality Owned by Me” and cooperation within and between departments.

19. Other special projects/assignments as designated by management

Education

• Bachelor's degree (B.S.) from four-year college or university with 3 to 5 years of quality/engineering related experience/training preferred; or equivalent combination of education and experience in a medical device regulated industry.
• Minimum Associate’s degree (A.S.) in technical field and 5 to 7 years of quality/engineering related experience/training or equivalent combination of education and experience.

Job Experience

• Medical Device experience including; ISO 13485, GMPs, MDD, CMDR.
• Sterilization experience.
• Supplier Quality management experience.
• Process and product validation experience.
• Working knowledge of Geometric Dimensioning & Tolerance including ability to read, analyze, and interpret procedures, engineering blueprints and drawings, and governmental regulations.
• Hands on experience in diagnosing, troubleshooting, and problem solving.
• Certification preferred (e.g. CQE, CQA, Six Sigma, Lean)