QA Electrical Engineer (Medical Device)

QA Engineer (Electrical)
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)


BS Electrical Engineering degree minimum.
3 years minimum Electrical Engineering experience in a manufacturing environment
Knowledge of medical device technical standards a plus (UL 2601, IEC 601 [safety, EMC, x-ray])

Skills and Knowledge:
Strong electrical/electronic troubleshooting skills.
Circuit design including microcontrollers, DSP, logic circuits.
Knowledge of LabView preferred
Programming skills a plus.
Strong written and oral English skills

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Reference number US_EN_2_027647_141408