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Job Title: Medical devices – Quality Engineer

Location: Twin Cities Metro Area, MN

Pay range: $60 - $63/HR

Role Overview

This position is part of the Field CAPA and Design Quality team, responsible for leading cross-functional efforts to identify root causes and implement effective solutions for complex, high-impact product performance issues. The role supports Active Implantable devices and accessories within a cardiac and diagnostic-focused portfolio. This opportunity is ideal for a technically strong professional who enjoys solving complex problems, leading initiatives, and driving projects to completion. The individual will collaborate with teams across R&D, Regulatory, Marketing, Medical Safety, Manufacturing, Post-Market, and Quality to ensure optimal outcomes. Additional contributions will include support for design quality initiatives such as risk management, product development, and lifecycle sustainment.

Key Responsibilities

- Lead cross-functional investigations into complex product performance issues, particularly where design-related root causes are suspected, including Nonconforming Events (NCEPs), CAPAs, and potential field actions.
- Apply structured problem-solving methodologies (e.g., DMAIC, Root Cause Analysis, 5 Whys, Fishbone Diagram, Is/Is Not) to identify and resolve technical challenges.
- Build and maintain strong partnerships across multiple teams and sites, providing technical direction and influencing decision-making.
- Develop and maintain thorough investigation documentation in accordance with Good Documentation Practices.
- Author, review, and approve quality system records related to CAPA and nonconformance processes.
- Communicate findings and updates effectively to stakeholders at all levels, including senior leadership.
- Mentor and support engineers and teams by sharing technical expertise and best practices in investigation and CAPA execution.
- Drive continuous improvement initiatives within Design Assurance and broader quality organizations.
- Ensure adherence to internal policies, procedures, and regulatory requirements.
- Uphold a strong commitment to product quality and patient safety through compliance with quality systems and standards.

Quality Responsibilities

- Integrate quality into all aspects of work by adhering to established quality standards and procedures.
- Ensure compliance with all applicable quality system requirements and policies.

Minimum Qualifications

- Bachelor’s degree in Engineering or a related field, with at least 4 years of relevant experience.
- Working knowledge of Quality System Regulations (QSR), Medical Device Regulations (MDR), and ISO 13485 standards.
- Experience within the medical device industry.
- Hands-on experience with nonconformance handling, CAPA processes, and investigation methodologies.
- Strong analytical and problem-solving skills with a data-driven approach.
- Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

Preferred Qualifications

- Experience with active implantable medical devices.
- Familiarity with statistical tools such as Minitab or Weibull analysis.
- Demonstrated ability to manage multiple priorities in a dynamic environment.
- Experience leading projects or working across cross-functional teams.
- Strong communication skills with the ability to influence and engage stakeholders.
- Experience working across diverse engineering disciplines (e.g., software, hardware, labeling).
- Proactive mindset with a focus on identifying improvement opportunities.
- Comfortable presenting to large groups, including senior leadership.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.