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Associate Quality Engineer

Location

Port Washington, NY

Description

GENERAL STATEMENT OF DUTIES:
Primary responsibilities involve sample reviews, execution of verification test programs, SCAR and CAR handling, technical expertise advisement for Post Market, Regulatory, Quality Control, Retail, Marketing, Sourcing, and Product Management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Works under the direct management of a Quality Engineer
  • Responsible for checking, documentation, and verification of new or replicated prototype products
  • Responsible for implementing QE tasks for new product concepts
  • Assist in development of verification test programs with guidance from Regulatory and as requested by Product Management and utilization of established international standards
  • Procurement and interpretation of technical files as required by Regulatory and as needed by Product Management
  • Manage SCAR and CAR activity through resolution
  • Assist Post Market, QC and Risk during investigation of product complaints or adverse incidents
  • Responsible for providing and communicating updates and reports on various projects to stakeholders on a regular basis
  • Manage verification test program details including quote, sample size, and turnaround time
  • Assist in creation of SOP and Work Instructions to maximize efficiency and effectiveness of various processes within Compliance and Regulatory
  • Create reports and documents to communicate engineering data, effectively, companywide
  • Responsible for working with suppliers or 3rd party entities on a regular basis
  • Document product changes and notify appropriate stakeholders with required information
  • Other duties may be assigned.

Requirements

QUALIFICATIONS:

  • Background in engineering fields such as Mechanical, Electrical, Chemical, or related technical fields such as Materials Engineering
  • A 4-year degree in engineering fields such as mechanical, electrical, chemical, or related fields such as Quality and Materials Engineering is required.
  • Ability to communicate effectively both internally and with suppliers via email
  • Must be able to recognize, seek, define, and resolve a variety of issues to obtain unique objectives as requested by Management
  • Ability to manage time to efficiently complete projects and tasks
  • Translate and/or implement Standard Operating Procedures
  • Fundamental understanding or ability to comprehend test procedures, technical documents, and/or established industry standards such as ISO and ASTM.
  • Read and translate test reports to effectively communicate results with cross functioning teams
  • Understanding of technical drawings/specifications
  • Technical writing skills
  • Knowledge of basic measuring devices such as calipers, micrometers, etc.
  • Detail oriented
  • Ability to connect product function(s) with test program(s)
  • Proficient in Microsoft Office including Outlook, Word, Excel (pivot table), Visio, and Power Point

GOOD TO HAVE:

  • Understanding of GMP, ISO 13485, and ISO 90001

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