Product Quality Engineer (Atlanta)

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 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

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.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit

https : / / www.akkodis.com / en / privacy-policy

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 Act

Los Angeles City Fair Chance Ordinance

Los Angeles County Fair Chance Ordinance for Employers

San Francisco Fair Chance Ordinance