Previous Job
Previous
Sr Quality Engineer (Medical Device)
Ref No.: 18-20408
Location: North Haven, Connecticut
Start Date / End Date: 04/23/2018 to 10/04/2019
Company: Artech Information Systems
Job Title: Sr Quality Engineer
Location: North Haven, CT
Duration: 6+ months
Job ID: 18-20408
 
This position is intended to be a Temp to Perm position on the Quality Engineering team.
 
Must Haves:
  • Experience as a Quality Engineer in the Design Verification phase of the product development lifecycle
  • Experience in Test Method development, Test Method Validation & Statistical Analysis
  • Experience with electromechanical medical device products or complex electromechanical products in another industry.
 
POSITION DESCRIPTION:
Performs Quality Engineering functions in support of projects associated to product development/change including: design verification (Design for Six Sigma), reliability engineering, component specification /approval, process evaluation and nonconforming product analysis in a product team environment. Ensure that component and finished devices are properly specified and inspected, and the associated manufacturing processes are properly designed, analyzed and validated.
 
POSITION RESPONSIBILITIES:
  • Overall responsibility for ensuring the adequacy of design quality for a Minimally Invasive Surgical
  • System, including documentation and other supporting quality evidence.
  • Facilitating and managing Design and Process FMEAs/FMECAs in a research and development
  • setting for the Surgeon User Interface and potentially other subsystems within the Minimally Invasive Surgical System.
  • Providing guidance and oversight of the plans and methods for verification and regressing testing.
  • Providing guidance on the principles of electrical engineering and IEC standards as they relate to the new product development activities of electromechanical medical devices.
  • Providing oversight and approval for Reliability Plans and ensure that they are properly executed
  • throughout the development and qualification processes.
  • Participating in the development of Test Methods, Test Method Validations and subsequent approval Engineering Report.
  • Ensure all fixtures, gages and tools used for the purposes of Design Verification have been properly validated per internal Design Control procedures.
  • Participate in Defect / Issue Management and Change Control Boards, as appropriate.
  • Support in the construction of the Risk Management Process per ISO 14971 at a System Engineering level.
  • Initiating corrective action requests on non-conformances (internal or external) and verifying the
  • effectiveness of corrective actions.
  • Contributing to the development of Process Flows, Control Plans, Design of Experiments,
  • Measurement Systems Analyses, and Process Capability Analyses.
  • Ensuring all FDA and ISO validation requirements are met and for the review and approval of all
  • validation protocols (IQ, OQ, PQ and MSA).
  • Ensure internal Design Control policies and procedures comply with regulations and external
  • standards, including software regulations, risk management, and change control.
  • Contribute to the streamlining and continuous improvement of the product development process to
  • ensure robust and efficient development and launch of new and innovative products.
  • Provide guidance for the application of internal development procedures, including Design Control,
  • to the product development teams, within the framework of regulatory requirements.
  • Interact and form constructive working relationships with all levels of leadership within Quality, Test Engineering Procurement, Marketing, R&D, and Operations.
  • Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.
 
EDUCATION REQUIRED:
BS Degree in Engineering, Math or Physical Science
 
YEARS OF EXPERIENCE:
Minimum (7) seven years' experience in design, manufacturing or quality engineering position
(medical device experience preferred). Three years of experience can be substituted for an
Advanced degree in a related discipline. Experience with analytical tools and methods, including
statistics (Minitab preferred), DOE, and the use of computer software packages related to design,
development and manufacturing. Statistical Quality Control/Statistical Process Control, Design
of Experiments, Failure Mode and Effects Analysis. Experience in a regulated environment
(FDA, ISO, etc.)
 
SPECIALIZED KNOWLEDGE REQUIRED:
  • Good communication skills, both written and oral and must be computer literate.
  • Knowledge of or experience in developing and manufacturing medical devices in conformance with
  • Quality System Regulations, ISO 14971, ISO 13485 requirements.
  • Knowledge of analytical tools and methods, including statistics (Minitab preferred), DOE and the use of computer/software packages related to design, development and manufacturing.
 
Preferred Skills/Qualifications:
  • ASQ Certified Quality Engineering (CQE), Certified Quality Auditor (CQA)
  • Six Sigma Green belt or Black Belt certified
  • Geometric Dimension and Tolerance (GD&T) o Knowledge and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO9001, 13485, and 14971 requirements.
 
Thanks
Rajiv Maruthi
Rajiv.maruthi@artechinfo.com