Quality Engineer-Medical Device-Westwood, MA

Westwood Permanent USD80,000 - USD90,000
  • Terrific Culture and Competitive Compensation Package
  • Strong Upward Mobility Offered

About Our Client

My client began by offering coatings for industrial purposes: you wanted it, you sent it; they coated it. In fact, one of the pioneers in the development of electrostatically applied powder coatings, Applied Plastics have been working with medical OEMs for over 30 years. As a result of their attentiveness to customer needs, the company started to receive more and more requests for lubricious coatings, higher volumes and continuous lengths of wire.

They are now in a period of continuous growth and are looking to add to their engineering team.

Job Description

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Description

  • Supports the maintenance of the QMS ensuring its continuing suitability, adequacy and effectiveness
  • Corrective and Preventive Action System (CAPA) ownership
  • Customer Returned Material Authorization System (RMA) ownership
  • Manages the Equipment Qualification and Validation System (including IQ, OQ and PQ, etc) a. Works with Manufacturing and Engineering to draft and execute protocols
  • Nonconforming Material System (NCMR) ownership and leads the MRB process where applicable
  • Performs First Article Inspections (FAI) with QC Personnel
  • Where applicable creates and executes Measurement System Analysis (Gage R&R)
  • Interface directly with customers to support technical issues and continuous improvement
  • Support day to day operations to drive Key Process Indicator (KPI) improvements and business objectives
  • Supports the Approved Supplier List (ASL) Evaluations, Reporting and Feedback
  • Creates and edits Standard Operating Procedures, Work Instructions and Forms
  • Performs Product Quality Inspections as needed
  • Performs Measuring and Monitoring Equipment Calibration as needed
  • Performs Training as needed 15. Perform other relevant duties as assigned by supervisor

The Successful Applicant

  • Full understanding of a QMS and conformance to ISO13485:2016
  • Experience in medical component or medical device manufacturing required
  • Proficient in use of metrology (hand devices, vision systems, microscopes, non-contact devices, profilometer)
  • Basic proficiency in reading drawings and blueprints
  • Ability to read, listen and communicate effectively in English, both verbally and in writing
  • Experience in customer, registrar or FDA audits/inspections a plus
  • Ability to navigate a computer ERP system, in certain modules, and perform data entry, data retrieval
  • Computer Skills - Microsoft Office Suite: Word, Excel, PowerPoint, Visio required (QMS software experience a plus)
  • Willingness to continually work beyond scope of essential duties in order to assist whenever and wherever needed to ensure company needs are met

What's on Offer

My client offer a compeitive base salary with bonus structure and terrific benefits.

Contact
Daniel Hall
Quote job ref
1552933

Job summary

Sub Sector
Location
Contract Type
Consultant name
Daniel Hall
Job Reference
1552933