Stevanato Group · 3 hours ago
Quality Engineer
Fishers, IN
Full-time
Onsite
Mid LevelStevanato Group is hiring Quality Engineers to help grow their plastics division. The Quality Engineer will support all aspects of the Quality Management System and ensure high quality and reliable products through various quality control practices and collaboration with cross-functional teams.
Health CareManufacturingPharmaceutical
Hiring Manager
Alisa Norris
Responsibilities
Track and report key Quality metrics
Author, review, or approve technical reports evaluating trends and process/product performance data, identifying and clustering issues based on type, complexity and time using statistical methods
Collaborate with cross functional team to investigate and trend deviations/OOS and customer complaints to identify CAPA to drive improvements to product quality. This may include authoring, reviewing, or approving investigation reports as well as conducting/facilitating root cause investigations and owning/executing resulting CAPA activities
Plan and perform regular audits of quality system and drive system improvements through the CAPA system
Locally deploy global quality and technical specifications for products and services in cooperation with internal stakeholders
Verify customer product specifications aligns with site capabilities to support customer quality expectations and implement efficient tools in handling SG and customer specifications compliant with applicable regulations
Maintain repository for the relevant technical and quality documents ensuring a systematic and standard approach to facilitating knowledge sharing and availability of documentation
Participates in carrying out new projects ensuring technical assistance and validation, as well as consultation with R&D Team to define appropriate processes to guarantee the quality and reliability of the products
Supports the definition of the required qualification and validation activities, aimed at ensuring the compliance of the quality management system with applicable standards and requirements
Provides timely and accurate validation documents, including creation/review/approval of internal protocols and reports as well as consultation/review/approval of thirds party protocols and reports
Collaborate with Operations and Engineering to ensure execution of the qualification and validation activities meet and timing and requirements defined in the approved plan, guaranteeing the compliance with applicable standards
Support the development and manufacturing of medical devices in conformance with applicable US FDA and ISO 13485 requirements
Ensure policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control
Build appropriate guidelines and best practices to support and facilitate the communication pursuing a trustful partnership with internal stakeholders, in line with the applicable standards and policies
Train quality staff in standard metrology, GD&T, SPC and new inspection techniques
Responsible for quality planning of all new development programs and design transfers to the site
Executes the assigned projects related to product and process quality improvement, including development and implementation of any new or required inspection methods
Collaborate with Operations, Process/Facility Engineers, and/or Validation Engineers to execute process and equipment qualifications
Qualification
Required
Experience in Quality Assurance/Quality Engineering/Process Engineering in manufacturing
Bachelors of Science in Technical Field (i.e. Engineering, Material Science, Data Analytics, Statistics, etc.) or equivalent work experience
Strong Communication skills to varying audiences including ability to train technicians on complex technical topics and program specific quality standards
Knowledge of applicable regulatory standards such as ISO 9001, ISO 13485 and applicable FDA cGMPs
Benefits
Cafeteria onsite serving breakfast, lunch, and snacks - employees get a daily meal stipend
100% employer paid Dental and Vision benefits
Opportunity for growth, development, and advancement
3 weeks of PTO
10 paid holidays
8 sick days
Company
Stevanato Group
Founded in 1949, Stevanato Group is one of the world's largest providers of integrated containment and delivery solutions for the biopharmaceutical industry.
Founded in 1949
5001-10000 employees
H1B Sponsorship
Stevanato Group 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 (1)
2024 (2)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$796.75MKey Investors
BNL BNP ParibasBiomedical Advanced Research and Development Authority (BARDA)
2025-07-23Post Ipo Debt· $234.61M
2024-03-21Post Ipo Equity· $330M
2023-03-08Post Ipo Debt· $137.14M
Recent News
2025-11-07
2025-11-07
Company data provided by crunchbase