Akkodis is seeking a Sr. Quality Engineer II for a Contract position with a client based in Mansfield MA. The Sr. Quality Engineer II will utilize Quality Engineering tools and practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
Pay Rate: $50 -$52/Hr. on W2 (The rate may vary based on experience, education, geographic location, and other factors.
) Sr. Quality Engineer II Job Summar
y: ESSENTIAL DUTIES AND RESPONSIBILIT
IESTo perform this job successfully, an individual must be able to perform each essential duty satisfactori
ly. Primary responsibilities are
to:EUMDR Class II & III Compliance Proj
ectsWorks in a cross-functional team to assess Supplier Validations and general documentation for compliance with EUMDR requirements and perform required remediation activit
ies.Works with supplier base to identify gaps in EUMDR requirements, specifically related to Process Validat
ion.Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improveme
nts.Conduct benchmarking to develop more effective methods for improving qual
ity.Approve IQ, OQ, PQ, TMV, or Software Validati
ons.Develop, interpret, and implement appropriate process monitoring and control methods consistent with the level of process/product r
isk.Collect data and execute/conduct various analytical/statistical analyses and interpretations as part of process improvements and day-to-day supp
ort.Conduct investigation, bounding, documentation, review, and approval of nonconformances, CAPAs, and customer complaints. Escalation of quality issues as appropri
ate.Accountability and ownership for material identification, material segregation, and classification of defect types including the successful application of these techniques on a day-to-day basis in manufactur
ing.Analyze/review the effectiveness of preventive and corrective actions. Review root cause investigation according to an established process. It is also understood that an associate may receive special projects outside of this
list DESIRED MINIMUM QUALIFICA
TIONSMinimum required education and experience: Bachelor's degree or equivalent with 8+ years of experience, Master's degree with 5+ years of experience, Doctoral degree with 3+ years of exper
ienceThis position will require relevant experience working in manufacturing/operations. In-depth knowledge of product/process Risk Management (FDA and ISO standards) is requ
ired.Experience with a proven track record of implementing appropriate risk mitiga
tion.A good technical understanding of manufacturing equipment and processes is required. Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the posi
tion. TOOLS AND EQUIPMEN
T USEDAbility to utilize a computer, telephone, and copy machine as well as other office equi
pment.Strong computer skills required (Excel, Word, PowerPoint, Outlook,
etc.). PHYSICAL REQUI
REMENTSThe physical requirements listed in this section include but are not limited to, the motor/physical abilities and skills required of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the po
sition. ADVERSE WORKING CO
NDITIONSThe adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this p
osition. If you are interested in this Sr. Quality Engineer II job in Mansfield MA, then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com. If you have questions about the position, please contact Rohit Tiwari at (610) 735 9206 or Rohit.Tiwari@akkodis
group.com Equal Opportunity Employer/Veteran
s/DisabledBenefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and a 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which 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/priva