LanceSoft, Inc.
Sr. Product Quality Engineer
Location:
Atlanta, GA 30313
Duration:
12 Months
Shift:
8AM to 5PM
Description:
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.
Basic Qualifications
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.
Preferred Qualifications
Advanced 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.
Seniority level Mid-Senior level
Employment type Contract
Industry Pharmaceutical Manufacturing
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Atlanta, GA 30313
Duration:
12 Months
Shift:
8AM to 5PM
Description:
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.
Basic Qualifications
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.
Preferred Qualifications
Advanced 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.
Seniority level Mid-Senior level
Employment type Contract
Industry Pharmaceutical Manufacturing
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