Engineer, Product Analysis

RXinsider LTD.; Scottsdale (AZ); Hybrid; USD 75,000 - 110,000; Full time

Job summary

West is seeking a qualified Quality Engineer to lead the expansion and maintenance of the Quality System, analyze inspection and process data, and ensure resources meet site quality requirements.

You will drive continuous improvement, generate quality reports, and support CAPA, PFMEA, and audit activities while ensuring compliance with cGMP and company policies. This hybrid role requires onsite presence three days per week and no relocation.

Qualifications

• Bachelor's Degree in Engineering or Business required.
• 3+ years of quality engineering experience in engineering/pharma/medical device manufacturing.
• 3+ years using computer-based measuring equipment (CMM).
• Familiarity with ISO 9001 and cGMP.

Responsibilities

• Drive site and departmental goals in quality improvement (Cost of Poor Quality, Yield).
• Provide accurate quality reports and perform trend analysis.
• Develop design control deliverables: quality plans, docs, test methods.
• Lead CAPA investigations and corrective actions.
• Develop and maintain PFMEA and risk analyses.
• Schedule calibration and monitor machine output.

Skills

Quality engineering

CAPA / root cause

Cross-functional collaboration

Education

Bachelor's Degree in Engineering or Business

Tools

Coordinate Measuring Machine (CMM)

Milling machines

Surface grinders

Job description

Description

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per 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.

Job Summary

In this role, you will be responsible to control all Quality functions including the expansion and maintenance of the Quality System, provide support for product and process improvements by collecting, compiling, and analyzing inspection and process date, and ensure the effective use of resources to meet site quality requirements.

Essential Duties And Responsibilities

• Drive site and departmental goals/KPI’s in the improvement of Cost of Poor Quality and Yield Opportunity to 100%
• Meet Company and Department goals in the continuous improvement of tooling products, services, and processes
• Provide accurate quality reports and perform trend analysis on assigned areas of responsibility
• Work independently and with project teams to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and any necessary records for filing tooling product history files.
• Support quality assurance improvement activities by evaluating products, processes, and data to develop control or improvement strategies intended to improve the Customer Experience.
• Participate in the development and maintenance of product risk and hazard analysis (PFMEA)
• Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process SPC programs.
• Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventative actions to preclude recurrence (CAPA).
• Identify and remedy equipment and/or process documentation gaps and provide appropriate training where needed.
• Support both Corporate and facility driven initiatives intended to meet defined objectives, including Quality System planning and audit support.
• Analyze data, process capabilities, customer concerns and expectations and any other leading or lagging indicators which may be used to improve product and process knowledge.
• Interact with customers to understand and integrate those requirements into West manufacturing and quality system requirements.
• Perform supplier non-conformance investigation and response.
• Conduct activities in accordance with the company Quality Policies/Procedures at all times - Comply with company cGMP regulations and be responsible for defect recognition.
• Schedule and maintain department machine calibration requirements and results.
• Monitor and document daily output performance and unmanned hours in your department.
• Perform other duties as assigned based on business needs.
• Conform with and abide by all regulations, policies, work procedures, instructions, and all safety rules - exhibit regular, reliable, punctual, and predictable attendance.

Education

• Bachelor's Degree in Engineering or Business required

Work Experience

• 3+ years of experience in a Quality engineering role at an engineering, pharmaceutical, or medical device manufacturer required
• 3+ years of experience in the use of computer-based measuring equipment (e.g., Coordinate Measuring Machine) required
• Experience in conventional toolroom machinery (mills, lathes, surfaces grinders) preferred

Preferred Knowledge, Skills And Abilities

• Knowledge of ISO 9001, cGMP
• Proficiency in all Microsoft Office applications.
• Flexibility in providing support beyond normal working hours when necessary.
• Awareness of all relevant SOPs/SOIs as per Company policy as they are related to the position covered by this job description.
• Always comply with the Company’s Safety and Quality Policies
• Trained Quality Auditor.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Formal apprenticeship or training in an engineering background.
• Knowledge of SPC
• Knowledge of “Lean Manufacturing” techniques.