Hubot | Tri Pac, Inc. CDMO · 17 hours ago
Quality Engineer
South Bend, IN
Full-time
Onsite
Senior Level
5+ years expHubot Tri-Pac, Inc. is a contract development and manufacturing company specializing in liquid and aerosol filling for personal care and pharmaceutical marketers. The Quality Engineer oversees the manufacturing and engineering processes to ensure product quality and compliance while driving continual improvement initiatives.
Consumer GoodsMedical Device
Responsibilities
Supports efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality. Ensures that decisions are made based on sound Quality principles and regulatory guidelines
Supports/leads failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions. Identifies areas of systemic weakness and leads initiatives to implement corrective action. Promotes use of statistical analysis for determination of improvements, and provides analyses to support risk mitigation
Implement and monitor all procedures and processes as they relate to Quarantine, Hold, Expired, Damages, Return Goods and Recalled product
Evaluate proposed changes for design control requirements. Guides engineering/ manufacturing personnel of appropriate qualification, validation criteria
Provides routine analysis of performance indicators and identifies trends. Presents this information to management, supervisors and manufacturing operators. Supports/leads initiatives to improve performance
Supports/leads teams to update risk management files for process changes. Focus team on implementing capable processes, process controls, and error-proofing measures
Collaborates with functional process owners to train, mentor and/or facilitate QMS requirements and continuous improvement
Monitoring the in-process quality check on the line
Reviews new Batch records and SOPs
Other duties as assigned
Qualification
Required
BA or BS Degree in Engineering, Quality Control or related field
5 years relevant experience in Quality Engineering/manufacturing/ production processes
Familiarity with industrial automation (e.g., distributed control and PLC-based systems)
Working knowledge of safety, quality systems, and GMPs is required
Benefits
Competitive Salary/ Pay & Packages
Vacations
Insurance
401K
Life Insurance
Disability (Long term/ Short term)
Continuous Training
Education Assistance
Company
Hubot | Tri Pac, Inc. CDMO
Hubot CDMO | Tri Pac, Inc.
51-200 employees
H1B Sponsorship
Hubot | Tri Pac, Inc. CDMO 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 (4)
2024 (1)
2023 (4)
2022 (6)
2021 (1)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Dr Pushker Sona
Chief Executive Officer
CA. Shankar V N
Chief Financial Officer
Company data provided by crunchbase