myGwork - LGBTQ+ Business Community · 2 days ago

Engineer III, QA

Ward Hill, MA

Full-time

Onsite

Entry, Mid Level

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Responsibilities

Support SQM team and core SQM processes with onboarding of new suppliers and materials;

Assign, track and reconcile GMP documentation;

Support Quality activities for key processes including Vendor/Supplier Change Notifications (VCN/SCNs) and Supplier Corrective Action Requests (SCARs);

Establish and implement Quality Technical Agreements with suppliers;

Construct internal and external audits as well as regulatory inspections;

Support supplier status changes as required to ensure that the Approved Supplier (Vendor) List is accurate and complete; and

Maintain filing system for the supplier quality documentation.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

GMP RegulationsQuality AssuranceChange ControlsQMS AuditingCAPAQuality System RegulationsSupplierMaterial Risk EstimationMicrosoft OfficeAdobe Software SuitesSmartsheet WorkAppsLeading Cross-functional MeetingsTriage of Supplier/Vendor NotificationsData AnalysisTechnical WritingProblem-SolvingCommunicationLeadership

Required

Master's degree or foreign degree equivalent in Mechanical Engineering, Industrial Engineering, or a related field of study plus 0 years of experience

Bachelor's degree or foreign degree equivalent in Mechanical Engineering, Industrial Engineering, or a related field of study plus 2 years of manufacturing quality assurance experience or related experience as an equivalent alternative

GMP Regulations

Quality Assurance

Change Controls

QMS Auditing

CAPA

Quality System regulations

Supplier and Material Risk estimation

Microsoft Office - MS Excel, MS Word, and MS PowerPoint

Adobe Software Suites - Adobe Acrobat, Adobe Sign

Smartsheet WorkApps

Leading Cross-functional meetings

Triage of Supplier/Vendor Notifications