Technical Quality Engineer (3969)
Company: Avanos Medical
Location: Alpharetta
Posted on: June 23, 2022
Job Description:
The roleThe major purpose of this position is to Lead the
on-going activities required to support the assigned product
category activities.These activities include, but are not limited
to: Support design changes, product enhancements, material changes,
and process changes; investigation of product non-conformances;
communication with customers, ensure compliance to quality system
requirements; support Avanos operated manufacturing facilities and
supply base; support acquisitions and integrations.Essential Duties
and Responsibilities:
- Actively participates in and/or facilitate the development of
deliverables required to qualify product changes ensuring that
customer requirements and specifications are met
- Maintains the Risk Management files which includes Hazards
Analysis, Design FMEA, Use FMEA & Process FMEA for assigned product
families
- Solves challenging technical problems, provides expertise in
related specific field of knowledge and consults on complex issues
and projects
- Works within cross-functional teams to lead investigation of
customer product complaints
- Utilizes Root Cause Analysis concepts to investigate issues and
implement Corrective and Preventive Actions including effectiveness
checks
- Ensures timely closure of active complaints providing tracking
and trending data
- Leads Global Post Market Surveillance analysis, trending, and
reporting
- Participate in internal and external audits
- Participate in and lead due diligence and integration
activities as needed
- Partners with vendors to facilitate the completion of Supplier
Corrective Actions and to build quality relationships
- Develops, initiates, and implements new quality concepts, tools
and strategies to improve business practices
- Assists with the transfer of knowledge of technical skills and
is viewed as a Subject Matter Expert
- Assist in development of Technical Documentation
- Conducts self in accordance with the expected Avanos values and
behaviorsYour qualificationsRequired:
- B.S. in Engineering, Science or Statistics
- A minimum of 3 years of collective experience in medical device
product development, quality assurance or manufacturing
- Process and Test Method validation experience
- Experience in Risk Management (ISO 14971)
- Experience in Quality Systems (ISO 13485)
- Proficient with Microsoft Office Programs
- Strong Technical Writing
- Ability to travel up to 20%, some internationalPreferred:
- Strong understanding of statistical concepts
- Strong understanding of design and development
- Understanding of Six Sigma/ Lean Manufacturing statistical
concepts
Keywords: Avanos Medical, Alpharetta , Technical Quality Engineer (3969), IT / Software / Systems , Alpharetta, Georgia
Didn't find what you're looking for? Search again!
Loading more jobs...