Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Supplier Quality Engineer is within our Infectious Disease Developed Markets business unit located at all sites under Abbott Diagnostics Scarborough QMS . This role will perform daily activities required to ensure that all purchased or otherwise received materials, products and services that can impact the quality of product or service provided conform to predefined requirements and quality attributes.

What You'll Do

• 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.

EDUCATION AND EXPERIENCE YOU'LL BRING

REQUIRED:

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

• 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.

• 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.

• Ability to interpret data and make sound judgments based on those interpretations is required.

• Must be able to adapt to quickly changing priorities and schedules.

• Ability to maintain good working relationships with all co-workers and outside contracts is required.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

The base pay for this position is $57,300.00 – $114,700.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com