Memphis, Tennessee, United States
Job type: fulltime
Job industry: Other
We are currently seeking a Quality Engineer for our client in Memphis TN.
Provide quality engineering floor support for production area to ensure production is able to expand capacity and volumes. Document, evaluate, and disposition any non-conformances associated with production. Support receiving inspection and in process inspection personnel. Enable optimization of any inspection efficiencies. Document, evaluate, and disposition any non-conformances identified during inspection. Document, evaluate, and record process validation protocols, testing, and reports for process optimization related to current production and future production of new designs. Initiate, identify root cause, evaluate, and document corrective and preventive action following the Quality Management System requirements for CAPA. Complete inspection and evaluation of finished products in pre-sterile quarantine, post-sterile quarantine, and finished goods kitting locations. Ensure full conformance to specification requirements. Assist in the transfer of production activities to a 2nd manufacturing location to enable increased production capacity. Ensure conformance to requirements for all manufacturing locations. Ensure that quality reporting (e.g. incoming and in-process quality trends; returns analysis, categorization and corrective action activity, etc.) is maintained and documented with the assigned team;
REQUIREMENTS Travel Some travel required Education Bachelor's degree in Engineering. Licenses/Certifications Experience Quality Engineer, Minimum 3-5 years in Medical Device / Biologics / IVD manufacturing experience. Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR and ISO 13485
About Advantage Resourcing
Advantage Resourcing is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.