Development Quality Engineer
Salary undisclosed
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Job Title: Development Quality Engineer
Location: St. Paul, MN Onsite
Duration: 12-Month Contract
Job Description:
We are seeking a Development Quality Engineer II with 2-5 years of experience to support quality disciplines, design control deliverables, and risk management activities within the medical device industry. The role requires strong problem-solving skills, cross-functional collaboration, and expertise in quality systems compliance.
Key Responsibilities:
- Lead and support design control deliverables for product development and design change projects.
- Ensure on-time execution of Quality Plans for internal Product Development Process (PDP) and OEM-based Clinical Product Development (CPDP).
- Develop and execute design verification test plans and reports for product/system requirements.
- Lead and support Risk Management activities, including hazard analysis, FMECA, and cybersecurity risk assessments.
- Identify Essential Outputs and generate related reports.
- Oversee completion of labeling verification activities and reports.
- Collaborate with design engineering on product requirements, verification, and validation.
- Ensure Design History File (DHF) integrity, content completion, and regulatory compliance.
- Perform timely and objective document change request reviews.
- Implement process control systems to support development, qualification, and manufacturing.
- Assist with CAPA systems, assurance processes, and business system improvements.
- Apply systematic problem-solving methodologies to resolve quality issues.
- Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory compliance.
Qualifications:
- Bachelor’s degree in Engineering or a related technical field.
- 2-5 years of experience in quality engineering, product development, or regulatory compliance.
- Strong skills in verbal and written communication, teamwork, multitasking, and organization.
- Proficiency in risk management, design verification, and regulatory standards.
- Advanced computer skills and experience with quality systems in a regulated environment.