Quality Engineer - Validation

Stevanato Group; Fishers (IN); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Brand new facility in Fishers LifeScI/

Meal stipend for onsite cafeteria

Dental and Vision benefits paid by the

Growth opportunities and advancement

Paid PTO and holidays

Job summary

Stevanato Group in Fishers, IN seeks a Quality Engineer to support the Quality Management System, product realization, and manufacturing process controls. You will apply quality control best practices to ensure materials and processes produce high-quality medical devices, partnering cross-functionally to build quality plans and process controls.

You will lead validation activities, drive CAPA, investigate deviations and customer complaints, and engage with customers to define acceptance criteria

Qualifications

• 3–5 years experience in Quality or Process Engineering in manufacturing.
• Bachelor degree in a technical field or equivalent work experience.
• Strong communication and ability to train technicians on standards.
• Problem-solving skills and project management ability.
• Familiarity with ISO 9001, ISO 13485, and FDA cGMP requirements.
• Knowledge of metrology, GD&T, and statistical methods.

Responsibilities

• Track and report quality metrics; author technical reports using statistics.
• Investigate deviations and customer complaints; drive CAPA ownership.
• Identify and implement continuous improvements in quality processes.
• Perform quality system audits and drive improvements via CAPA.
• Deploy quality specs locally and verify alignment with site capabilities.
• Maintain quality documentation repository for knowledge sharing.
• Support projects with technical assistance and validation with R&D.
• Define/execute qualification and validation activities; author protocols.
• Ensure FDA/ISO 13485 conformance of development and manufacturing.
• Train staff in metrology, GD&T, SPC, and inspection techniques.
• Own quality planning for new development and design transfers.
• Develop inspection methods; collaborate on equipment qualifications.
• Support internal and external audits and inspections.
• Engage with stakeholders and participate in customer technical meetings.

Skills

Communication skills

Problem solving

Risk-based thinking

Metrology

GD&T (ANSI Y-14.5)

Statistical methods

Education

Bachelor's in Engineering / Materials / Data Analytics / Statistics

Tools

CAPA system

Quality management systems

FDA/cGMP knowledge

Job description

We're looking for a Quality Engineer to support our Quality Management System, product realization, and manufacturing process controls. In this role, you'll apply quality control best practices to ensure the materials, components, processes, and manufacturing techniques we use produce high-quality, reliable products. You'll partner cross-functionally to build quality control plans and process controls, lead validation activities and statistical analysis, drive process capability studies, and investigate deviations and customer complaints to resolve technical quality issues. You'll also engage directly with customers to address quality concerns and define acceptance criteria.

We are unable to sponsor work visas for this position, including but not limited to H-1B, TN, or OPT/CPT extensions requiring employer sponsorship.

Responsibilities:

• Track and report key quality metrics; author and review technical reports evaluating trends and process/product performance using statistical methods
• Collaborate cross-functionally to investigate and trend deviations, OOS events, and customer complaints - driving CAPA to improve product quality, including root cause investigations and CAPA ownership
• Identify and implement continuous improvement opportunities across quality processes
• Plan and perform regular quality system audits, driving improvements through the CAPA system
• Deploy global quality and technical specifications locally, and verify customer specifications align with site capabilities
• Maintain a repository of technical and quality documentation for consistent knowledge sharing
• Support new projects with technical assistance and validation, partnering with R&D on process design
• Define and execute qualification/validation activities, including authoring, reviewing, and approving protocols and reports
• Ensure development and manufacturing of medical devices conforms to FDA and ISO 13485 requirements
• Train quality staff in metrology, GD&T, SPC, and new inspection techniques
• Own quality planning for new development programs and design transfers
• Develop and implement new inspection methods; collaborate with Operations and Engineering on process/equipment qualifications
• Support internal and external audits and inspections
• Build strong working relationships with internal stakeholders and participate in customer technical meetings

Requirements:

• 3-5 years of experience in Quality Engineering, or Process Engineering in a manufacturing environment
• Bachelor of Science in a technical field (Engineering, Material Science, Data Analytics, Statistics, or similar), or equivalent work experience
• Strong communication skills, including the ability to train technicians on complex technical and program-specific quality standards
• Strong problem-solving and project management skills
• Risk-based thinking approach and strong technical writing ability
• Working knowledge of ISO 9001, ISO 13485, and FDA cGMP requirements
• Familiarity with manufacturing processes and control strategies in medical device and/or pharmaceutical industries
• Proficiency in metrology, calibration, and Geometric Dimensioning and Tolerancing (ANSI Y-14.5)
• Working knowledge of statistical methods used in manufacturing

Why Work With Us?

• Brand new facility located in the Fishers Life Sciences and Innovation Park
• Cafeteria onsite serving breakfast, lunch, and snacks - employees get a daily meal stipend
• 100% employer paid Dental and Vision benefits
• Modern space with brand new technology, climate-controlled production floor
• Opportunity for growth, development, and advancement
• 3 weeks of PTO, 10 paid holidays, 8 sick days

We are an equal opportunity employer and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, veteran status, or any other legally protected status.