Quality Engineer II

Job Summary

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 fall into the categories of change management, non-conformance management, and partnership with the 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 a variety of engineering organizations to ensure a consistent approach to incorporating compliance to quality management systems within production processes.
• Address manufacturing cell escalations as they are raised through the operations quality organization.
• Identify continuous improvement opportunities to improve 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.

Qualifications

Working Conditions

Benefits

The salary range for this position is $80,000 – $95,000 per year. Minnetronix offers a competitive Total Rewards package including health, dental, vision, 401K, time off, and eligibility for an annual bonus program. Base salary varies with experience, qualifications, and location.

EEO Statement

Minnetronix Medical provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetic information, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation and training.

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