Quality Engineer - Life Sciences

About the role

The Quality Engineer supports Tennant Solutions' quality management system and quality assurance activities within a regulated medical device, clinical trial, and healthcare products fulfillment environment. This role partners cross-functionally to ensure compliance with ISO 9001, ISO 13485, FDA Quality System Regulation (21 CFR Part 820), and applicable customer and regulatory requirements. The Quality Engineer will actively own/support audits, supplier quality management, nonconformance investigations, corrective and preventive actions, and continuous improvement initiatives. The ideal candidate has prior experience working within ISO 13485-certified and FDA-regulated environments and can effectively contribute with limited training and oversight to regulated quality systems and processes.

Responsibilities

• Support the execution of quality activities in alignment with ISO 9001, ISO 13485, and FDA 21 CFR Part 820 requirements.
• Support the establishment, review, verification, and maintenance of Design History Files (DHFs), Device Master Records (DMRs), and associated product lifecycle documentation, ensuring compliance with ISO 13485, FDA regulatory requirements, and applicable customer specifications.
• Participate in and support audits, including preparation, on-site execution, documentation, and follow-up.
• Aid in supplier qualification, onboarding, and ongoing performance monitoring.
• Support investigation and resolution of internal and supplier-related nonconformances and corrective action requests.
• Track, trend, and report on quality metrics and performance indicators.
• Review documentation for completeness and compliance.
• Maintain quality documentation within the eQMS (Salesforce/Dot Compliance preferred).
• Collaborate with cross-functional teams to address quality risks.
• As needed, take operational control during quality-related situations or events, providing leadership, direction, and coordination.
• Participate in continuous improvement initiatives related to quality processes.

Qualifications

• Bachelor’s degree in Engineering, Quality, or a related technical field.
• 2-5 years of experience in quality engineering, manufacturing quality, supplier quality, or a related quality function.
• Demonstrated experience working within an ISO 13485-certified quality management system.
• Experience supporting compliance activities in FDA-regulated medical device environments, including familiarity with FDA Quality System Regulation (21 CFR Part 820) and/or FDA medical device registration requirements.
• Working knowledge of nonconformance management, CAPA, root cause investigation, and quality risk management methodologies.
• Strong organizational, analytical, problem-solving, and written and verbal communication skills.
• Willingness and ability to travel to supplier sites as required.
• Ability to work on-site.
• Proven ability to collaborate cross-functionally.
• Experience with supplier qualification, supplier audits, and supplier quality management. Working knowledge of ISO 9001.
• Experience supporting in regulatory inspections, internal/external, and/or supplier audits.
• Experience with Salesforce and/or Dot Compliance (eQMS).
• Formal training in root cause analysis, CAPA, Lean, Six Sigma, or continuous improvement methodologies.

Location

On-site

Travel Required

Up to 10% regional travel