Senior Quality Engineer

Greiner•Monroe, NC

25d

About The Position

This role is responsible for ensuring products adhere to company and industry quality standards by setting detailed guidelines on inspection and testing requirements. The Senior Quality Engineer will develop inspection methods, identify and lead CAPA and process improvement initiatives, and develop, maintain, and monitor measurement processes to ensure compliance with ISO and FDA regulations. This position also involves collaborating with suppliers to investigate root causes and corrective actions for deficiencies, monitoring supplier processes, and deploying variation management tools at select suppliers. Additionally, the role includes auditing suppliers, establishing supplier quality requirements, and reporting on supplier trends. The Senior Quality Engineer will design and implement methods for process control, improvement, testing, and inspection, and establish and maintain process flow diagrams, workplace layouts, FMEAs, and standardized work instructions. Other duties may be assigned.

Requirements

Bachelor’s degree in engineering field or related field.
3-7 years of experience in high volume regulated manufacturing industry in engineering field.
Working experience of Six Sigma, lean and Quality Management Tools
A broad knowledge of theory and principles of statistics and statistical process control
Experience with Access Database, Excel and complaint handling software.
In-depth knowledge of ISO13485, ISO14971, CFR part 820.
Good understanding of medical device regulation, industry, and international standards.
Strong computer skills in MS Office
Ability to recognize and projects
Ability to read and understand technical drawings and documents
Working experience on CAD/SolidWorks
Ability to work independently and take initiative
Excellent communication, analytical, trouble-shooting and interpersonal skills
ASQ Lead Auditor or equivalent training in auditing
A team player as well as the ability to work independently

Nice To Haves

Master’s degree in engineering is preferred.

Responsibilities

Set detailed guidelines on inspection and testing requirements
Ensure products adhere to company and industry quality standards
Develop inspection methods to analyze product quality
Identify and lead CAPA and process improvement initiatives
Develops, maintains and monitor measurement processes to ensure compliance to ISO and FDA regulations.
Collaborate with supplier to investigate root cause and corrective actions when raw material or component deficiencies are detected
Monitor and evaluate supplier process for compliance to purchase order and engineering requirements
Deploy variation management tools and techniques at select suppliers to mitigate risk
Audit suppliers and establish supplier quality requirements
Reporting on supplier trends for management review and notification of identified trends to management for management review
Design and implements methods for process control, process improvement, testing, and inspection
Establish and maintains process flow diagrams, workplace layouts, FMEAs and standardize work instructions
Other duties as assigned