Job Description

JobTitle: Quality Assurance Engineer
Location: Brooklyn Center, MN

Experience: 5+ years
Duration: 12+ Months Contract

The Quality Assurance Engineer will support the integration, maintenance, and continuous improvement of Quality Management System (QMS) processes across multiple sites. This role involves close collaboration with cross-functional teams including Quality, Operations, Supply Chain, and Development to ensure compliance with regulatory standards while driving operational efficiency. The specialist will also lead audit readiness activities, manage quality documentation, and support process harmonization initiatives within a regulated environment.

• Collaborate with cross-functional core teams to integrate and standardize QMS processes across various locations.

• Analyze interactions between QMS elements and coordinate with stakeholders to ensure robust, compliant, and efficient systems.

• Partner with program managers to plan, update, and execute changes to quality system documentation such as procedures, manuals, quality plans, and agreements.

• Coordinate with impacted departments to ensure necessary training is identified and implemented effectively.

• Provide oversight for the development, implementation, and continuous improvement of quality programs and procedures that meet internal and regulatory requirements.

• Interpret and apply relevant regulatory standards and guidelines to ensure ongoing compliance.

• Support internal and external audits, including preparation, response to findings, and communication with auditors and inspectors.

• Oversee quality assurance programs and recommend updates to align with business and compliance needs.

• Coordinate responses for legal and regulatory investigations or information requests.

• Promote consistency in quality standards and processes across global operations and encourage the adoption of best practices.

• Bachelor's degree in Engineering, Science, or a related field.

• Minimum of 5 years of relevant experience, or an advanced degree with at least 3 years of relevant experience.

• Proven background in quality systems within a regulated industry such as medical devices or pharmaceuticals.

• Hands-on experience with QMS implementation and process management.

• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).

• Strong communication and cross-functional collaboration skills.

• Lean or Six Sigma certification.

• Experience in project management and risk mitigation activities.

• Prior involvement in mergers, acquisitions, or large-scale process integration projects.

• Solid understanding of FDA regulations (21 CFR Part 820 and Part 11) and ISO 13485 standards.

• Strong analytical, critical thinking, and problem-solving abilities.

• Experience using Product Lifecycle Management (PLM) tools such as Agile or Windchill.

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