eTeam ยท 10 hours ago
Supplier Quality Engineer
Cheswick, PA
Contract
Onsite
Mid Level
4+ years expeTeam 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
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
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
eTeam is a staffing agency that also provides payrolling services.
501-1000 employees
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)
Funding
Current Stage
Late StageTotal Funding
unknown2023-12-04Acquired
Leadership Team
Swetta Bhatt
CEO APAC & India
Aanchal Thakur
Chief Customer Officer
Recent News
2025-11-19
2025-08-21
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