United Pharma · 8 hours ago
Supplier Quality Remediation Engineer
Massachusetts, United States
Contract
Onsite
Senior Level
5+ years expUnited Pharma is seeking a Supplier Quality Remediation Engineer to support supplier remediation activities following an FDA 483 observation. This role will lead supplier gap assessments and remediation efforts, focusing on aligning design and process risk controls to regulatory expectations.
Staffing & Recruiting
Hiring Manager
Chandra Sekhar.s
Responsibilities
Lead supplier gap assessments and remediation efforts
Evaluate supplier process controls using advanced quality engineering methodologies
Ensure high-severity risks are appropriately identified, mitigated, and sustained in compliance with FDA and ISO requirements
Collaborate with suppliers to execute corrective actions
Review validation activities
Communicate findings and action plans to internal stakeholders
Qualification
Required
Bachelor's degree in engineering
5+ years of experience in medical device or other regulated manufacturing environments
Strong expertise in dFMEA and pFMEA (with emphasis on severity ratings)
Process capability analysis (cPk)
IQ/OQ/PQ
Measurement System Analysis
Hands-on collaboration with suppliers to execute corrective actions
Review validation activities
Communicate findings and action plans to internal stakeholders
Preferred
Experience supporting supplier remediation following regulatory observations
Working knowledge of FDA QSR
ISO 13485
ISO 14971
Blueprint reading
Statistical tools such as Minitab
Company
United Pharma
United Pharma Solutions is a professional company dedicated to business development in the pharmaceutical industry.
11-50 employees
H1B Sponsorship
United Pharma 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
Early StageCompany data provided by crunchbase