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Abbott · 1 week ago

Engineer, Supplier Development Quality

Scarborough, ME

Contract

Onsite

New Grad, Entry Level

0+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Supplier Development Quality Engineer will be responsible for supplier selection and evaluation, material qualification, and ensuring that all received materials conform to quality requirements.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Maintain the Supplier Quality Function, working closely with and supporting Purchasing and the New Product Development and Engineering team(s)

Respond in a timely and professional manner to internal and external suppler requests that pertain to quality

Manage supplier changes through the change management system

Review Supplier Validation Protocols to ensure they meet regulatory and customer requirements

Work closely with the engineering team to schedule and drive and review purchased product first article inspections, capability studies, gage R&Rs, etc

Investigate and drive to completion root cause analysis of product quality issues and defects for new and sustaining purchased products and implement solutions to resolve issues; assist other personnel, as required, with the Corrective Action process specific to purchased components and/or services

Manage the Supplier corrective action process, drive improvement to the ASL

Utilize supplier Scorecards/metrics and analytical tools to quantify performance levels of individual suppliers and work with those suppliers to develop improvement plans to achieve quality performance goals

Establish and execute priorities to achieve expectations

Identify and implement continual improvement opportunities to streamline quality systems and processes

Perform external audits, as required, based on the published audit schedule and/or as needed if suppliers are struggling to achieve established quality metrics

Other duties as required

Qualification

Supplier Quality EngineeringChange Management SystemsRegulatory ComplianceMicrosoft Office SuiteTechnical WritingOrganizational SkillsAttention to DetailVerbal CommunicationWritten CommunicationRelationship BuildingAdaptability

Required

BS in Engineering, Manufacturing, Biology or related discipline, or equivalent combination of education and experience

0-2 years' experience in medical device industry, preferably in Quality or Supplier Engineering

Demonstrated proficiency using Microsoft Word, PowerPoint, and Excel

Preferred

Familiarity with federal and other regulations, e.g. QSR's, ISO 13485, CMDR, IVDD/IVDR. Working knowledge of the General Provisions of 21 CFR Part 11 for Electronic Records and Electronic Signatures preferred

Experience with change management systems is preferred

High level of proficiency in Microsoft Office Suite of software applications is required

High level of attention to detail and accuracy is required

Strong organizational skills and ability to prioritize tasks is required

Exceptional documentation and technical writing skills is required

Excellent verbal and written English language skills is required

Ability to establish and maintain strong, effective working relationships with internal employees and external customers is required

Ability to react quickly and adapt to changes in priorities, circumstances and direction is required

Must be able to reason independently and work with minimum supervision