Clinton, MA, USA
7 days ago
Quality Systems Engineer
At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

 

Customer Complaints Program

Facilitate the CC process for ensuring that corrective actions are completed in accordance with relevant ISO requirements (ISO 13485, ISO 14971 & FDA 21 CFR part 820), Jabil Advance Problem Solving methods, and that documentation is complete and compliant with requirementsAs a Complaints Coordinator, the Quality Systems Engineer shall facilitate efficient and effective processing customer complaintsRegularly communicate with Engineering, Quality, and manufacturing to implement robust CC within defined timelineTrack and Trend CC metrics including but not limited to weekly and monthly CC metricsCoordinate with cross-functional team for root cause analysis and corrective & preventive actionsConduct Verification of Effectiveness for the CCsPrepare for, participate and driveCC Review Board meetings and get required support from senior management team for CC implementationComplete harmonization and gap assessment reviews for documents associated to CC processFacilitate meetings with customer to support closure of open CCs and respond to customer queriesFacilitate investigations on Return Material Authorization requests submitted by customerObtain Customer Score Cards for Jabil Healthcare and coordinate with Site Quality and the  Work Cell Managers to implement actions if needed

Audit Support

Assists with internal audits, external audits, and FDA inspectionsParticipates in Second/Third party audits and provides input to Jabil response to any findingsActs as a member of the review room during audits.

Quality Engineering Support

As required, assists in development of quality plans, work instructions, procedures, harmonization, periodic document reviews, change controls, process change authorizations etc.May perform other quality related duties and responsibilities as assigned

Job Specifications: 

B.S in a Technical or Applied Science discipline (or equivalent Quality / Process / Project / Automation / Injection Molding experience), with 3-5 years engineering experienceMust have strong verbal and written communication and interpersonal skillsOrganizational and planning skills are required to plan, execute, and track quality commitmentsStrong problem-solving skillsAbility to multitask and perform efficiently and independentlyKnowledge of various quality system methodologies such as 8D, Lean, 5 Why’s, Pareto Analysis, PFMEA, PPAP etc. preferredInternship / experience in the regulated industry with standards such as cGMP/QSR, ISO 13485 and 21CFR 820 Part 11 preferred

 

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Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.

 

Accessibility Accommodation  

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com or calling 727-803-7988 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.

 

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