Quality Engineer

The Quality Engineer supports the development, maintenance, and continuous improvement of the work site's Quality Management System (QMS). This position is focused on learning and assisting with routine quality activities such as document control, internal audits, CAPA, change control, nonconforming product, and customer complaint tracking. The Quality Engineer will gain exposure to FDA, ISO, and other regulatory requirements.

Hybrid from Woodbury, MN

• Assist in maintaining QMS documentation (SOPs, work instructions, forms) and ensuring document control activities are current.
• Support the change control process which includes preparing change requests, routing for review, and filing records.
• Participate in internal, external, and supplier audits and audit followup as well as documenting findings and tracking corrective actions under guidance.
• Assist in investigating customer complaints and documenting results in the complaint handling system.
• Help manage CAPAs which includes collecting data, drafting CAPA records, monitoring implementation progress, and verifying effectiveness.
• Maintain calibration and training records for equipment and personnel as assigned.

• Participate in quality improvement projects and crossfunctional team meetings as directed.
• Assist in preparing for external audits and inspections.
• Support regulatory submission activities by gathering and assembling required QMS records.

• Bachelor's Degree in Engineering, Life Sciences, or a related technical discipline.
• experience in a quality role within an ISOcertified environment or manufacturing setting.
• Familiar with basic quality tools and terminology (e.g., audit, CAPA, document control).
• Proficiency with Microsoft Office Suite.
• Ability to organize, take notes, and manage Microsoft Teams meetings with domestic and international team members.
• Interpersonal skills including effective collaboration and communication skills.
• Adaptable with the ability to work in an ever-changing environment.

• Experience working in an ISO 13485:2016 or FDA 21 CFR Part 820 environment.
• Internship, Coop, or job experience in a medical device or regulated industry.
• Experience with electronic QMS platforms (e.g., eQMS).

• Comprehensive benefits package including medical, dental, and vision insurance.
• Generous Paid Time Off including paid holidays and floating holidays.
• 401(k) employer match on retirement planning.
• Hybrid working schedule for eligible positions.
• Tuition reimbursement on approved programs.
• Flexible and health spending accounts.
• Talent Development program.

Minimum Salary: $79,202

Maximum Salary: $122,763

We consider various factors in determining actual pay including your skills, qualifications, and experience. In addition to salary, this position is eligible for incentive awards based on individual and business performance as well as competitive benefits.

Minimum Salary: $79,202

Maximum Salary: $122,763

We consider various factors in determining actual pay including your skills, qualifications, and experience. In addition to salary, this position is eligible for incentive awards based on individual and business performance as well as competitive benefits.