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Supplier Development Quality Engineer
3 months ago
Job Title: Supplier Development Quality Engineer
Work Site: Scarborough, ME 04074
Duration: 04 Months Contract with possible extension
Shift/Schedule: 1st shift: 8am - 5pm [Monday - Friday]
Pay Rate: $45/hr on w2 w/o benefits.
Job Description:
- 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.
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.
