Yoh, A Day & Zimmermann Company · 5 hours ago
Quality Engineer
Noblesville, IN
Full-time
Onsite
Entry, Mid Level
$66K/yr - $94K/yr
2+ years expYoh, A Day & Zimmermann Company is hiring a Quality Engineer for a Pharmaceutical Manufacturing client in Indiana. The role involves maintaining compliance with regulatory guidelines, managing reliability improvement initiatives, and investigating customer complaints to ensure quality standards are met.
AccountingConsultingHuman ResourcesBookkeeping and PayrollStaffing Agency
Hiring Manager
Scott Savage
Responsibilities
Maintain and manage to closure a list of reliability related improvement efforts for operations and engineering
Manages projects or initiatives specifically related to reliability improvements
Author and review Change Control / Quality Documents involving product or process changes
Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Review validations (equipment, cleaning and/or process) for assigned area
Prepares and participates in regulatory agency (i.e. FDA, HC, TGA, etc.) audits as well as internal audits
QA contact for risk management activities, including FMEA’s (Failure Modes and Effects Analysis)
Investigate customer complaints, deviations / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented in the sites EQMS (Electronic Quality Management System)
Assemble, analyze and report batch data to ensure regulatory compliance, identify trends and to identify areas of improvement
Develop, review and/or revise SOP (Standard Operating Procedures), BR’s (Batch Records), OJT/OJQs, FMEA’s with appropriate change management
Ability to adapt quickly in a fast-paced dynamic environment
Ability to quickly investigate and close deviation records ahead of product release
Ability to communicate with and positively influence broad and diverse cross-functional teams within and outside the organization
Qualification
Required
Bachelor's degree in Life Sciences or Engineering required
2 or more years of relevant experience required
Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Significant experience investigating deviations and other variances, using Quality Engineering Tools and Techniques (i.e. RCA tools such as but not limited to 5-Whys, Fishbone/6M, TapRoot, Kepner-Tregoe, Comparative Analysis)
Must be thoroughly familiar with applicable US and international regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems
Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes
Must have experience with statistical tools
Preferred
Pharmaceutical experience preferred
Working knowledge of cGMP guidelines and their application in a controlled aseptic environment is strongly preferred
Certification in Lean or Six Sigma preferred
Benefits
Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
Health Savings Account (HSA) (for employees working 20+ hours per week)
Life & Disability Insurance (for employees working 20+ hours per week)
MetLife Voluntary Benefits
Employee Assistance Program (EAP)
401K Retirement Savings Plan
Direct Deposit & weekly epayroll
Referral Bonus Programs
Certification and training opportunities
Company
Yoh, A Day & Zimmermann Company
When progress demands experience, that’s where we come in.
1001-5000 employees
H1B Sponsorship
Yoh, A Day & Zimmermann Company 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)
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Trends of Total Sponsorships
2025 (57)
2024 (28)
2023 (27)
2022 (25)
2021 (28)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Peter Melomo
Vice President, Sales Strategy & Professional Consulting Services
Tom Enright
VP Recruiting - Specialty Practices
Recent News
Philadelphia Business Journal
2025-01-11
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