Quality Engineer III in North Haven, CT at APEX Systems

Date Posted: 3/8/2018

Job Snapshot

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Job Description

Job #:  828845

Seeking a senior level Quality Engineer with a minimum of 7 years' experience. To be considered for this role, you must possess strong design verification experience in a product development life cycle, test method development, test method validation, statistical analysis, and experience with electromechanical products. For immediate consideration, please send your updated resume to zburrell@apexlifesciences.com


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 an another industry.


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. 



  • 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.


  • BS Degree in Engineering, Math or Physical Science


  • 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.)


  • 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) \
    • Knowledge and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO9001, 13485, and 14971 requirements.


Job Requirements

Physical capabilities to perform the job:

  • While performing the duties of this job, the employee is regularly required to be independently mobile.  The employee is also required to use a computer, and communicate with peers and co-workers via a variety of media including telephone, email, instant message, social networking platforms, and in-person meetings.


Office environment where the employee would be standing and sitting most of the day at a desk or in a conference room for meetings.