Quality Engineer

Stevanato Group S.p.A.•Fishers, IN

5d•Onsite

About The Position

The Quality Engineer supports the Quality Management System, product realization, and manufacturing process controls. The role applies quality-control best practices to help ensure materials, components, processes, and manufacturing techniques produce high-quality, reliable products. Working with cross-functional partners, the Quality Engineer defines and generates quality control plans, production process controls, and procedures; leads and supports validation activities, including statistical analysis; performs process capability analyses; and investigates deviations and customer complaints to resolve technical quality issues. The role also engages with customers to investigate and address quality issues and define acceptance criteria and attributes. The position supports quality monitoring, documentation, validation, regulatory compliance, project execution, audits, inspections, and stakeholder relationships. It is based onsite, with periodic flexibility to meet business needs. Work may occur in professional offices, ISO 7 or 8 clean rooms, glass-forming, needle-assembly and packaging facilities, and limited warehouse areas. Periodic off-shift support may be required.

Requirements

3–5 years of experience in Quality Assurance, Quality Engineering, or Process Engineering in manufacturing.
Bachelor of Science in a technical field such as Engineering, Materials Science, Data Analytics, or Statistics, or equivalent work experience.
Strong communication skills, including the ability to train technicians on complex technical topics and program-specific quality standards.
Strong problem-solving skills.
Strong project-management skills.
Risk-based thinking approach.
Strong technical-writing skills.
Knowledge of applicable regulatory standards, including ISO 9001, ISO 13485, and applicable FDA cGMPs.
Knowledge of technologies and control strategies for relevant medical-device and/or pharmaceutical manufacturing processes.
Knowledge of medical-device manufacturing Quality Management System processes and features.
Knowledge of project-management and risk-management methodologies, techniques, tools, and applications.
Proficiency in metrology and calibration techniques.
Working knowledge of statistical methods used in manufacturing.
Proficiency in Geometric Dimensioning and Tolerancing (ANSI Y-14.5).
Complete internal QMS training and relevant training on IT tools such as ERP, Office, and company applications.
Auditor training and training in SPC, process controls, metrology (GD&T), Gage R&R, and calibration.
Comply with designated-area PPE requirements, including safety glasses, safety shoes, hearing protection, and gowning.

Nice To Haves

Certifications such as ASQ CQE, CQA, or CQM are desired.

Responsibilities

Track and report key quality metrics; evaluate trends and product or process performance using statistical methods.
Collaborate with cross-functional teams to investigate and trend deviations, out-of-specification results, and customer complaints; identify and execute CAPA and conduct or facilitate root-cause investigations.
Identify and implement continuous-improvement solutions for performance metrics and quality processes.
Plan and perform quality-system audits and drive improvements through the CAPA system.
Deploy global quality and technical product and service specifications locally with internal stakeholders.
Verify that customer product specifications align with site capabilities and support customer quality expectations while maintaining compliant specification-handling tools.
Maintain a repository of relevant technical and quality documents using a systematic approach that facilitates knowledge sharing and document availability.
Support new projects with technical assistance and validation, consulting with R&D to define processes that ensure product quality and reliability.
Define required qualification and validation activities to ensure the quality management system meets applicable standards and requirements.
Create, review, and approve internal validation protocols and reports, and consult on or review and approve third-party protocols and reports.
Collaborate with Operations and Engineering to execute qualification and validation activities according to approved plans, timelines, and applicable standards.
Support 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.
Develop guidelines and best practices that support communication and partnership with internal stakeholders in accordance with applicable standards and policies.
Train quality staff in standard metrology, GD&T, SPC, and new inspection techniques.
Lead quality planning for new development programs and design transfers to the site.
Execute assigned product- and process-quality improvement projects, including developing and implementing new or required inspection methods.
Collaborate with Operations, Process/Facility Engineers, and Validation Engineers on process and equipment qualifications.
Support inspections and audits by providing requested information and, where applicable, explaining data, documentation, and rationale to inspectors or customers.
Communicate regularly with internal leaders, teams, and relevant stakeholders to build awareness of the quality vision and support resolution of quality issues.
Participate in customer technical meetings to provide technical services on quality topics and help ensure customer requirements are understood and fulfilled.
Comply with safety requirements and promote a Safety First culture.