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SyllogisTeks · 5 hours ago

Quality Engineer

Cheswick, PA

Full-time

Onsite

Mid, Senior Level

$55/hr - $65/hr

4+ years exp

SyllogisTeks is focused on ensuring the quality of materials and services used in manufacturing medical devices. They are seeking a Quality Engineer to lead supplier qualification activities and collaborate with various teams to align supplier capabilities with design intent.

Human ResourcesStaffing Agency

Comp. & Benefits

Hiring Manager

Judy Battocletti

Responsibilities

Lead supplier qualification activities for new components and processes to support production launch readiness of a new medical device

Plan, execute, and document component and process qualification activities

Review and interpret supplier documentation to support qualifications such as FAIs, pFMEAs, Control Plans, Process Flow Diagrams, IQ/OQ/PQs

Ensure supplier process capability meets design and quality requirements through capability studies (Cpk) and statistical analysis

Collaborate with R&D Mechanical and Electrical Design Engineers, and other internal stakeholders, to ensure supplier capabilities and manufactured parts align with design intent and resolve discrepancies

Serve as the quality interface between the R&D organization and selected suppliers

Qualification

Quality EngineeringQualification methodologiesStatistical analysisEngineering drawings interpretationRisk-based decision makingTechnical problem solvingSupplier relationship managementCommunication skillsCross-functional collaborationAttention to detail

Required

Bachelor's degree in engineering, or other related technical discipline required

4-7 of experience in a quality-related role within a regulated industry (medical device preferred)

Strong working knowledge of qualification and validation methodologies, including IQ/OQ/PQs, pFMEAs, Control Planes, Capability studies (Cpk), Gage R&R and measurement system analysis, First Article Inspections

Ability to interpret engineering drawings, specifications, and technical requirements

Strong written and verbal communication skills, including supplier-facing interactions