United Pharma Technologies Inc · 17 hours ago
Quality Engineer
Massachusetts, United States
Contract
Onsite
Mid LevelUnited Pharma Technologies Inc is seeking a Medical Device Quality Engineer to support manufacturing and quality system activities in a regulated medical device environment. This role will focus on compliance, process validation, risk management, and continuous improvement while partnering closely with cross-functional teams.
BiotechnologyData ManagementHealth CareMedicalPharmaceutical
Hiring Manager
Hemasundar Annam
Responsibilities
Ensure compliance with global medical device quality and regulatory requirements
Support manufacturing quality activities, including process validation and risk management
Apply statistical methods and Six Sigma tools to drive continuous improvement
Perform root cause analysis and support CAPA investigations
Utilize SAP QM and/or SPC software to monitor and analyze quality data
Support internal and external audits and inspection readiness
Prepare and maintain clear, accurate quality documentation
Collaborate and influence cross-functional teams to resolve quality issues
Qualification
Required
Master's degree in Engineering, Quality, Life Sciences, or a related field
Manufacturing experience in the medical device or other regulated industry
Green Belt Six Sigma and/or DRM (Design for Reliability/Manufacturability) training or certification
Experience with SAP QM and/or SPC software
Strong verbal, written, analytical, and interpersonal skills
Working knowledge of the following regulations and standards: FDA QSR (21 CFR Part 820), Canadian Medical Device Regulations (CMDR), EU Medical Device Directive (93/42/EEC), JPAL, ISO 13485:2016
Demonstrated experience with process validation, statistical methods, and risk management
Preferred
ASQ certification preferred (CQE, CQA, CBA) or equivalent
Company
United Pharma Technologies Inc
United Pharma Technologies (UPT) is a global life-science services company delivering CQV, validation, quality, automation, and regulatory compliance solutions to the pharmaceutical, biotechnology, medical device, and diagnostics sectors.
Founded in 2010
201-500 employees
H1B Sponsorship
United Pharma Technologies Inc 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 (50)
2024 (81)
2023 (77)
2022 (69)
2021 (46)
2020 (57)
Funding
Current Stage
Growth StageTotal Funding
unknown2022-07-18Acquired
Leadership Team
Babjee M
Founder/ Srategic Partner
Company data provided by crunchbase