QA Electrical Engineer

QA Engineer (Medical Dev; Mfg)

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

• 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)

• 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.

• 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.

• 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.

• 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.

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

Qualifications:

• 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.