Quality Engineer

Element Materials Technology • Minnetonka, MN

425d

About The Position

The Quality Engineer position at Element in Minnetonka is a critical role within the quality assurance team, responsible for influencing overall quality performance. The role involves managing the quality management system (QMS), ensuring compliance with client approvals, and improving processes to enhance quality outcomes. The successful candidate will interact with Medical Device clients and regulatory bodies, advising on the importance of quality and integrity in inspection and testing services. This position offers opportunities for career advancement within Element's quality organization.

Requirements

• Sound working knowledge of quality management system requirements.
• Experience in managing quality assurance processes in a laboratory setting.
• Ability to drive a culture of quality assurance and improvement.
• Strong communication skills for interaction with clients and regulatory bodies.
• Experience with accreditation processes and regulatory compliance.

Nice To Haves

• Familiarity with ISO/IEC 17025 standards.
• Experience in the medical device industry.
• Knowledge of electronic quality management systems (eQMS).

Responsibilities

• Maintenance and scope extension of all accreditations (e.g. ISO/IEC 17025), customer approvals, and regulatory requirements.
• Implement and maintain the QMS, ensuring necessary controls are in place for inspection and testing.
• Manage the day-to-day implementation of the QMS and support colleagues in its execution.
• Prioritize activities to meet business, colleague, and customer needs.
• Drive a culture of quality assurance and improvement in laboratory operations.
• Ensure fulfillment of customer expectations through QMS implementation.
• Maintain and extend accreditations as agreed with management and the Quality Manager.
• Manage A2LA and customer assessments, responding to findings as required.
• Implement QA/QC programs to reduce costs of poor quality and improve compliance.
• Ensure effective training in the electronic quality management system (eQMS).
• Provide quality training to colleagues during onboarding and refresher training for existing staff.
• Conduct method audits, system audits, and proficiency testing as per established schedules.
• Maintain good working relationships with operational colleagues and the wider quality community.

Benefits

• Opportunities for career advancement within the quality organization.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: No Education Listed