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eTeam · 21 hours ago

Supplier Quality Engineer

Cheswick, PA

Contract

Onsite

Mid Level

4+ years exp

eTeam is responsible for ensuring the quality of supplied materials and services in the manufacturing of medical devices. The Supplier Quality Engineer will lead supplier qualification activities and collaborate with internal teams to ensure compliance with design and quality requirements.

Information Technology

Growth Opportunities

H1B Sponsor Likely

Hiring Manager

Kalpana M

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

Qualification methodologiesCapability studies (Cpk)First Article InspectionsISO 13485ISO 9001Technical problem solvingSupplier relationship managementCross-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

Preferred

Knowledge of manufacturing processes such as injection molding, PCB manufacturing and assembly, machining, and casting

Familiarity with ISO 13485 and ISO 9001

Company

eTeam

Glassdoor4.0

eTeam is a staffing agency that also provides payrolling services.

Founded in 1999

Somerset, New Jersey, USA

501-1000 employees

http://www.eteaminc.com

H1B Sponsorship

eTeam has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (36)

2024 (205)

2023 (11)

2022 (7)

2021 (24)

2020 (25)