Quality Engineer III

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Position Summary

The position is responsible for ensuring activities throughout the product lifecycle are compliant with applicable procedures, standards, and regulations. The role involves developing, applying, and implementing methods, tools, and practices to achieve product quality goals in design, development, production, distribution, maintenance, and service.

This is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development, and production controls.

Responsibilities

Key Accountabilities

• Participates in generating and reviewing quality documents throughout the product lifecycle.
• Advises teams on compliance with procedures, standards, and regulations.
• Ensures product quality meets requirements and documentation is complete before approval.
• Supports new product development and design changes.
• Advises on implementation of Design Control and Product Realization requirements.
• Provides guidance on tools and techniques for product development and performance investigations.
• Contributes to product requirements, acceptance criteria, traceability, and failure analysis.
• Applies sound statistical methods and quality tools to evaluate results related to design, risk, and production.
• Guides on software compliance, including cybersecurity and privacy standards.
• Reviews and approves change orders related to product and process modifications.
• Performs other duties as assigned.

Secondary Functions

• Identifies compliance gaps and implements corrective actions.
• Supports audits and quality system improvement projects.

Internal Networking/Key Relationships

Collaborates with other functions to generate compliant documentation, interpret quality procedures, and communicate requirements effectively. Negotiates and influences to enhance quality and compliance.

Qualifications

Skills & Capabilities:

• Knowledge of domestic and international quality/regulatory standards.
• Familiarity with Lean, Six Sigma, and statistical techniques.
• Understanding of IL products, manufacturing processes, and customer/patient impact.
• Judgment in applying regulatory requirements to data review, design changes, and risk management.
• Risk-based decision-making skills.
• Ability to escalate issues appropriately.

Minimum Knowledge & Experience

• Bachelor\’s degree or equivalent in engineering or science.
• At least 5 years of experience in medical devices, pharmaceuticals, diagnostics, or clinical labs, or 2 years with an advanced degree.

Additional Skills/Knowledge

• Broad knowledge of engineering and science principles, including R&D, quality control, manufacturing, and design engineering.
• Technical problem-solving skills.
• ASQ Quality Engineering Certification (desirable).
• Approximately 10% of time allocated.

If you are interested in continuous learning and daily challenges, please submit your resume or CV.

Werfen is an Equal Opportunity employer committed to diversity. We prohibit unlawful discrimination, harassment, or retaliation based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin, age, disability, medical condition, marital status, veteran status, or other protected characteristics. For accommodations, contact us.

We operate in over 30 countries, with more territories through distributors. Our annual revenue is around $2 billion, with over 7,000 employees worldwide.

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