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Quality Engineer

Location: North Haven, Connecticut Salary: competitive
Sector: Medical Devices, Engineering, Engineering & Validation, Quality Assurance (QA), Quality Assurance (QA) Type: Contract

I am working with a CT based Medical Device manufacturer who are looking for a Quality Engineer on a 2 year contract.

The successful Quality Engineer will need strong problem solving, communication, manufacturing process, and leadership skills as well as Lab operations/management and some experience of Process Validation and/or Root cause analysis experience. Key Responsibilities:

  • Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
  • Provide Quality Engineering support as a Process Validation team member and lead/execute Test Method Validations and Measurement Systems Analysis (MSA).
  • Work directly with component/raw material suppliers and Incoming Quality to include inspection plan creation and maintenance, PPAP (as applicable), and SCAR/NCR management.
  • Evaluate compliance of materials and/or processes with specification and customer requirements
  • Collect, analyze, interpret and summarize statistical data
  • Perform defect analysis on components and finished goods
  • Create validation protocols, summaries, and approvals
  • Initiate corrective action requests on discrepant product/processes and verify adequacy and accuracy of corrective action taken internally and/or externally
  • Assist in Design of Experiments to improve process/product
  • Assist other functions in the timely disposition of material to support operational objectives
  • Perform analyses and provide reports to management

Essential experience:

  • Bachelor's Degree in Chemistry, Biochemistry or Biochemical Engineering & 2 years of experience in Quality or Engineering or a relevant Masters degree
  • Project management experience (familiarity with Microsoft Project - Gantt Charts).
  • Familiarity with Lab operations/management. Process Validation and/or Root Cause Analysis experience.
  • Working knowledge of statistical methods and applications (Minitab experience a plus).

Desirable experience:

  • ASQ Certification desired
  • Working knowledge of Six Sigma, DFMEA, PFMEA and Risk Management Tools
  • Strong communication, manufacturing process, product industrialization and leadership skills
  • Solid design, troubleshooting and presentation skills
  • Strong project management skills
  • Well versed in molding, stamping and machining methods.
  • Tooling and processing experience a plus.
  • Experience in assembly equipment technologies
  • Analyze and chart statistical and process data using Minitab, MS Excel, or equivalent
  • Working knowledge of 21CFR820, ISO13485, Canadian MDR and MDD 93/42/EEC Knowledge of validation process protocol creation and summaries
  • Proficient in Project Management Familiar with the Product development process

*****This is a W2 contract only, no sponsorship!!*****

Sthree US is acting as an Employment Business in relation to this vacancy.