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Quality Engineer III at Apex Systems, Inc. in North Haven, CT

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Description

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.

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

PHYSICAL 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.

WORK ENVIRONMENT:

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


VEVRAA Federal Contractor
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.

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