Engineer, Supplier Development Quality

Title: Engineer, Supplier Development Quality

Location: Scarborough, ME

Duration: 6 Months (Possibility of Extension)

100% Onsite

DESCRIPTION

• Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet SJM and regulatory requirements.
• This position 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.

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.

BASIC QUALIFICATIONS | EDUCATION:

• 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.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

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, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.