Quality Engineer in Long Island City, New York at AccruePartners

Date Posted: 10/19/2019

Job Snapshot

Job Description

THE TEAM YOU WILL BE JOINING:

  • Established, global leader in its industry with over 100 year history specializing in advanced products and R&D
  • Operates in over 25 locations worldwide with revenues in excess of $4B
  • Innovative organization that is highly regarded in its industry

WHAT THEY OFFER YOU:

  • Company offers competitive compensation, a comprehensive benefits package, and opportunities for cross-functional involvement partnering with all aspects of the business.
  • Great company culture and people-focused environment.
  • Company offers great advancement opportunities.
  • Company also offers employee education assistance.

WHY THIS ROLE IS IMPORTANT:

  • Manage day to day technical, test/inspection, manufacturing, design, regulatory, documentation and other issues related to one or more medical device product lines

Test Fixture Design and Production

  • Design of manually operated or automated test fixtures to determine conformance to specifications for various components, sub-assemblies, and finished product.
  • Create requirements, drawings, schematics, instructions for use, maintenance instructions and other documentation associated with fixtures.
     

Product development process:

  • Provide input to engineering department to assist in the development of product requirements assuring that regulatory and performance specifications are included.
  • Lead Risk Analysis activities (familiarity with ISO 14971 standard)
  • Review and approve documents prepared by engineering including System Requirements, Verification Test Plan, Validation Test Plan, etc.
  • Actively participate in project team meetings and ensure that Quality department tasks are appropriately scheduled and assigned.
  • Review and approve user documentation to be provided with the product (Strong English skills)
     

Safety Testing and Regulatory Compliance

  • Participate in product testing activities such as in-house bench testing and beta testing.
  • Understand requirements of relevant medical device standards such as IEC/EN60601-1 and IEC/EN60601-1-2 and review test lab reports for correctness and comprehensiveness.
  • Prepare and ensure the continuing appropriateness, of Device Master Record / Technical File in accordance with regulatory requirements.
     

Manufacturing & Product Quality

  • Perform failure analysis for both in-process and finished goods.
  • Analyze field returns data to identify failure trends and quality problems.  Prepare associated statistical reports.
  • Establish and monitor Device History Records.
  • Review and approve manufacturing procedures
  • Review and approve process validation procedures and results (assess process capability, adequacy of equipment, facility, personnel).
  • Review and approve test procedures and oversee test process validation (adequacy of test equipment, assessment of measurement capability).
  • Perform periodic off-the-shelf product audits.
     

Supplier Quality

  • Perform supplier evaluation (monitor performance, conduct on-site and remote audits)
  • Communicate with suppliers to address quality problems.
  • Support personnel performing incoming inspection (provide technical assistance, interpret requirements).
  • Develop inspection sheets / instructions for incoming inspection.
     

Quality System

  • Conduct internal process audits and evaluate procedures, policies, employee skills and training, as well as other elements of the Quality System to ensure continuing certification to ISO 13485.
  • Review Non-conformance / corrective actions - ensure that N/C's are correctly documented identifying root cause and appropriate corrective action.

Documentation Management

  • Review and approve new as well as revised (ECO) drawings and documents
  • Monitor MRP system information (BOM's, inspection requirements, material descriptions, inventory levels)

THE BACKGROUND THAT FITS:

  • BS in Electrical Engineering minimum
  • 3 years minimum Electrical Engineering experience in a manufacturing environment
  • Strong electrical/electronic troubleshooting skills
  • Circuit design including microcontrollers, DSP, logic circuits
  • Knowledge of medical device technical standards a plus (UL 2601, IEC 601 [safety, EMC, x-ray])
  • Knowledge of LabView a plus
  • Programming skills a plus
  • Strong written and oral English skills

#LI-PM1