Quality Engineer (QE) - Three Point Solutions Inc

Job Title: Quality Engineer (QE)
Client: Medical Device Manufacturing
Duration: 12 Months
Location: Bloomington and/or Ramsey, MN (Remote option may be available)

Overview:

Client is seeking an experienced Quality Engineer (QE) to assist in the transition of their Quality Management System (QMS) from ISO 9001 to ISO 13485. This role involves leading the development, documentation, and implementation of new processes, ensuring compliance with medical device industry standards, and overseeing all quality-related activities for the organization. The ideal candidate will have expertise in both Quality Assurance (QA) and Quality Engineering (QE) practices, with a deep understanding of regulatory standards and risk management in the medical device sector.

Key Responsibilities:

1. ISO 13485 Transition:
   • Lead the conversion of the existing Quality System from ISO 9001 to ISO 13485.
   • Develop and implement new processes and procedures to meet ISO 13485 requirements.
   • Work closely with cross-functional teams (R&D, Manufacturing, Regulatory, etc.) to ensure smooth adoption of new quality processes.
2. Quality Assurance (QA) Activities:
   • Oversee documentation, quality systems, and the development of standard operating procedures (SOPs).
   • Manage post-market surveillance and complaint handling processes in compliance with ISO 13485.
   • Conduct internal audits to ensure continuous adherence to quality systems and ISO standards.
   • Maintain documentation control and ensure all quality records are up to date.
3. Interdisciplinary Collaboration:
   • Collaborate with R&D, Manufacturing, and Regulatory teams to ensure product design and manufacturing processes meet quality standards.
   • Provide input on product design reviews to ensure compliance with regulatory and quality requirements.
   • Lead continuous improvement initiatives aimed at enhancing product quality, reliability, and compliance.
4. Training and Knowledge Transfer:
   • Train internal teams on ISO 13485 requirements and the updated quality processes.
   • Ensure knowledge transfer and support ongoing education of teams regarding best practices in quality management and compliance.

Required Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Minimum of 5 years of experience in Quality Engineering or Quality Assurance, with specific expertise in medical devices.
• Hands-on experience with ISO 13485 quality system standards.
• Excellent project management skills and the ability to lead cross-functional teams.
• Strong analytical, communication, and problem-solving skills.

Preferred Qualifications:

• Experience working in medical device companies or similar highly regulated industries.
• Previous experience leading ISO standard transitions, especially from ISO 9001 to ISO 13485.
• Certification in ISO 13485 Lead Auditor or CQE (Certified Quality Engineer) is a plus.

Location:

• The position can be based in Bloomington or Ramsey, MN.
• Remote work may be an option, depending on the candidate's experience and qualifications.

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