Title – Product Quality Engineer
Location : Atlanta GA
Pay Range : $50 / hr. -$55 / hr. / hr. (The rate may be negotiable based on experience, education, geographic location, and other factors)
Contract : 12 Months+
Job 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 :
Bachelors 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 validationExperience in preparing risk assessments, FMEA and other risk documents.Preferred Qualifications :
Advanced Degree in Engineering / Technical FieldExperience 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"Equal Opportunity Employer / Veterans / Disabled
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer : These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and / or security clearance requirements, including, as applicable :
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance