Role: Supplier Quality Engineer

Location: Scarborough, ME - 04074

Duration: 05 Months

Shift Timings: 8 AM to 5 PM

Job Descrption:

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.

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.