ZealTech ยท 1 day ago
Quality Control Engineer
Pennsylvania, United States
Full-time
Onsite
Mid LevelZealTech is a company focused on quality control in design engineering. They are seeking a Quality Control Engineer to ensure compliance with design control standards and lead validation processes.
ConsultingInformation ServicesInformation TechnologyManagement ConsultingStaffing Agency
Hiring Manager
Rajesh Ganesan
Responsibilities
Collaborate with design engineering to develop, review, and approve Design Inputs/Outputs, Design History File (DHF) documentation, and Change Control implementation
Ensure full compliance with design control standards such as 21 CFR 820 and ISO 13485
Act as SME for design controls, design verification & validation (V&V), process validation, test method validation (TMV), and risk management per ISO 14971
Plan and execute risk management activities including hazard analysis, dFMEA, and pFMEA throughout the product lifecycle
Conduct Failure Modes and Effects Analysis (FMEA) and integrate findings into design and manufacturing processes
Lead or support design verification and validation planning, execution, protocol creation, and report writing
Oversee test method validation, statistical testing, and process validation to ensure traceability and compliance
Develop, revise, and ensure adherence to QMS procedures covering ISO 13485, cGMP, and 21 CFR Part 820, including document control, CAPA, and audit readiness
Support internal and supplier audits, regulatory inspections, and ensure follow-up with corrective actions
Investigate product deviations and process non-conformances, lead root cause analysis, and implement CAPA or NCR actions
Monitor the effectiveness of corrective actions and maintain relevant documentation
Qualify suppliers, review supplier documentation, and support pilot/production transfer to align with Critical to Quality (CTQ) requirements
Collaborate with manufacturing engineering to implement process improvements and validate manufacturing outputs
Stay current with relevant regulations (FDA, EU MDR, ISO 10993, etc.) and integrate best practices into quality systems
Provide regulatory submission support for 510(k) or similar filings
Qualification
Required
Collaborate with design engineering to develop, review, and approve Design Inputs/Outputs, Design History File (DHF) documentation, and Change Control implementation
Ensure full compliance with design control standards such as 21 CFR 820 and ISO 13485
Act as SME for design controls, design verification & validation (V&V), process validation, test method validation (TMV), and risk management per ISO 14971
Plan and execute risk management activities including hazard analysis, dFMEA, and pFMEA throughout the product lifecycle
Conduct Failure Modes and Effects Analysis (FMEA) and integrate findings into design and manufacturing processes
Lead or support design verification and validation planning, execution, protocol creation, and report writing
Oversee test method validation, statistical testing, and process validation to ensure traceability and compliance
Develop, revise, and ensure adherence to QMS procedures covering ISO 13485, cGMP, and 21 CFR Part 820, including document control, CAPA, and audit readiness
Support internal and supplier audits, regulatory inspections, and ensure follow-up with corrective actions
Investigate product deviations and process non-conformances, lead root cause analysis, and implement CAPA or NCR actions
Monitor the effectiveness of corrective actions and maintain relevant documentation
Qualify suppliers, review supplier documentation, and support pilot/production transfer to align with Critical to Quality (CTQ) requirements
Collaborate with manufacturing engineering to implement process improvements and validate manufacturing outputs
Stay current with relevant regulations (FDA, EU MDR, ISO 10993, etc.) and integrate best practices into quality systems
Provide regulatory submission support for 510(k) or similar filings
Company
ZealTech
ZealTech is a leading technology provider for onsite project consulting, staffing and IT solutions.
Founded in 2005
11-50 employees
H1B Sponsorship
ZealTech 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 (7)
2024 (7)
2023 (3)
2022 (7)
2021 (18)
2020 (9)
Funding
Current Stage
Early StageCompany data provided by crunchbase