Quality Engineer II

About the role

The Quality Engineer II serves as a member of our production support team for complex electronic and software-based medical devices. This role is part of the technical writing, decision-making, and customer-facing portion of the operations quality team and supports both the New Product Introduction (NPI) and commercial sides of the business. Routine activities include change management, non-conformance management, and partnership with development teams. Communication and collaboration with customers is required when applicable. This position plays a critical role in incorporating quality into processes and ensuring ongoing compliance with established quality management systems.

Responsibilities

• Author, consult, and approve product and system quality-related content to ensure risk-based evaluation of Engineering Change Orders, CAPAs, and planned deviations.
• Complete DHR review and formal written responses to customer feedback/complaints; collaborate on SCAR investigations and development of appropriate corrective and/or preventive actions.
• Review and approve re-work logs and non-conforming material reports; provide or confirm dispositions as required.
• Develop Manufacturing Control Plans, Master Validation Plans, and PFMEAs; support development of Validation/Qualification protocols.
• Collaborate with engineering organizations to ensure consistent compliance with quality management systems within production processes.
• Address manufacturing cell escalations as they arise through the operations quality organization.
• Identify continuous improvement opportunities to enhance the efficiency of quality management system processes.
• Support internal quality audits as required by the annual schedule.
• Serve as the Quality point of contact with customer organizations, as required.
• Other duties as assigned.

Requirements

• Bachelor’s degree in an engineering, technical, or scientific discipline.
• At least 2 years of relevant experience; medical device experience preferred.
• Experience in technical writing and presentation of engineering-based investigations.
• High proficiency in standard electronic business tools: Outlook, Word, PowerPoint, Excel, Visio.
• Effective communication skills to provide technical feedback internally and clear guidance/updates to external customers.
• Ability to evaluate risk and impact of changes and non-conforming conditions and make data-driven decisions.
• Passion for change, continuous improvement, and a strong sense of urgency.

Benefits

• Health, dental, and vision insurance.
• 401K plans.
• Time off programs.
• Eligibility to participate in an annual bonus program based on individual and organizational performance.

Pay

The salary range for this position is dependent upon the individual's skills, experience, qualifications, and applicable employment laws.

Must be authorized to work in the United States.