Quality Engineer

Location:

Greenfield, Indiana, US

Department:
Quality

Description:

This is an onsite position requiring the team member to be onsite 5 days a week.

No relocation is provided for this opportunity.

At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World war 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun.

A name started our story. How will yours help write our future?

There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

In this role, you will provide technical Quality Engineering support for technology transfer, qualification, validation, manufacturing processes, investigations, risk management, and ongoing commercial production. You will apply structured problem-solving, statistical, engineering, and risk-based methods to establish and maintain effective process controls, resolve complex product and process quality issues, and improve manufacturing performance. The Quality Engineer partners with Operations, Engineering, Validation, Laboratory, Quality Systems, Supplier Quality, and other functions supporting medical device, pharmaceutical packaging and drug-device combination product programs.

The role reports to the Quality Engineering Manager or Quality Operations Manager, as assigned.

• Ensure Quality Engineering activities comply with applicable regulatory requirements, corporate policies, procedures, Quality Agreements, company guiding principles, and the Code of Conduct.
• Promote Quality ownership, Right First Time execution, continuous improvement, and timely escalation of product quality or compliance risks.
• Interface with customers on technical quality matters, including product requirements, investigations, complaints, change controls, validation, risk assessments, and quality performance.
• Partner with Operations, Engineering, Validation, Manufacturing Science and Technology, Customer Quality, Supplier Quality, and other functions to resolve technical quality issues and maintain effective process controls.
• Provide Quality Engineering oversight for technology transfer, new product introduction, scale-up, manufacturing readiness, process performance qualification, and transition to routine commercial manufacture.
• Review and approve qualification and validation protocols and reports for equipment, processes, packaging, and computerized systems, as applicable.
• Translate customer and product requirements, Critical to Quality characteristics, and Quality Agreement responsibilities into effective manufacturing, inspection, and acceptance controls.
• Develop, review, and maintain quality specifications, inspection strategies, sampling plans, defect libraries, control plans, and manufacturing control strategies.
• Provide technical Quality input to product and process risk management, including PFMEA, risk assessments, control plans, and lifecycle maintenance of risk controls.
• Review and approve change controls affecting processes, equipment, facilities, materials, inspection methods, packaging configurations, software, or product quality.
• Lead investigations for assigned areas of process ownership and provide QA oversight and support for investigations led by other functions, ensuring appropriate root cause analysis, containment, corrective actions, and preventive actions.
• Develop and assess corrective and preventive actions addressing product, process, systemic, or recurring quality issues.
• Analyze manufacturing and quality data using appropriate statistical methods to identify adverse trends, assess process capability, and drive sustainable improvement.
• Document clear, timely, and risk-based Quality decisions, conclusions, and recommendations while maintaining appropriate Quality…