Sr. Product Quality Engineer

Atlanta, GA, US • Posted 60+ days ago • Updated 39 minutes ago

Full Time

On-site

Fitment

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Job Details

Skills

Partnership
Cross-functional Team
Customer Satisfaction
Design Controls
Product Requirements
Risk Management
Manufacturing
Process Engineering
Auditing
Management
Quality Management
QMS
Environmental Management
EMS
Element Management System
Collaboration
Research and Development
Process Manufacturing
Product Development
Test Methods
Risk Assessment
FMEA
Medical Devices
Requirements Management
IBM Rational DOORS
Reporting
JIRA
Statistics
Verification And Validation

Summary

Job Description:

This position is Non-exempt. Hours over 40 will be paid at Time and a Half.
The Sr. Product Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success. This individual will be leading and managing a risk management team but could also work on other items. Looking for someone well rounded from a development quality perspective.

Responsibilities:

Lead and/or support on-time completion of Design Control deliverables.
Support the establishment of objective, measurable, and verifiable product requirements.
Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities.
Lead Risk Management activities from product concept through commercialization.
Support test method development and lead test method validation activities.
Support manufacturing process development & qualification for new product and design changes.
Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications.
Support biocompatibility and sterilization qualifications.
Support audits and quality system improvement activities.
Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
Comply with Client, U.S. FDA, EUMDR and other requirements, as applicable.
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.

Requirements:

Bachelor's degree in engineering or Technical Field.
Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.
Experience in medical devices and associated regulations/standards.
Experience in test method development and validation.
Experience in preparing risk assessments, FMEA and other risk documents.
dvanced Degree in Engineering/Technical Field.
Experience in active implantable medical devices.
Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
Working knowledge of statistics and its application to verification and validation.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 2359960d1c5a47e523f7217e62cb3aaa
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Sr. Product Quality Engineer

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