Quality Engineer - Intellectt INC

Hello,
One of my clients is currently looking for a Quality Engineer. If you're interested or if your skills align with the role, please share your updated resume with me at sushma@intellectt.com. Job Title: Quality Engineer
Location: Minneapolis, Minnetonka, St. Paul, Minnesota
Contract Duration: 12 Months Job Summary:

We are seeking a highly skilled and detail-oriented Quality Engineer to support quality assurance and regulatory compliance activities in the medical device industry. This role requires expertise in quality systems, validation, risk management, and supplier quality to ensure that products meet regulatory standards and customer expectations.

Key Responsibilities:

• Ensure compliance with FDA Quality System Regulation (QSR), ISO 13485, ISO 14971, EU MDR, and other applicable standards.
• Develop, implement, and maintain quality system documentation, including SOPs, CAPAs, non-conformance reports (NCRs), and risk management files.
• Lead process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Perform root cause analysis and implement corrective and preventive actions (CAPA) to address quality issues.
• Conduct supplier audits and manage supplier quality, ensuring alignment with company and regulatory requirements.
• Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory) to support product development and manufacturing activities.
• Analyze quality data, including non-conformance trends, customer complaints, and internal audit findings, to recommend improvements.
• Participate in internal and external audits, including those conducted by FDA and ISO certification bodies.
• Support change control processes, assessing the impact of changes on product quality and compliance.
• Drive continuous improvement initiatives using Lean, Six Sigma, and other methodologies to enhance quality and reduce waste.
• Perform risk management activities per ISO 14971, including risk assessments and mitigation planning.
• Provide training and mentorship on quality processes, standards, and tools to team members.

Qualifications and Experience:

• Bachelor's degree in Engineering, Quality, Life Sciences, or related field.
• 3-7 years of experience in quality engineering, preferably in the medical device industry.
• Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and EU MDR.
• Proficiency in quality tools such as FMEA, Root Cause Analysis, Statistical Process Control (SPC), and MSA.
• Hands-on experience with process validation (IQ/OQ/PQ) and equipment qualification.
• Familiarity with quality management systems (QMS) such as TrackWise, MasterControl, or Agile PLM.
• Experience conducting supplier audits and managing supplier quality performance.
• Advanced skills in data analysis and statistical software (e.g., Minitab, JMP).
• Strong technical writing skills for creating and maintaining quality documentation.
• Excellent project management, organizational, and communication skills.

Preferred Skills:

• Certified Quality Engineer (CQE) or Six Sigma certification (Green Belt or higher).
• Knowledge of software validation (CSV) for regulated environments.
• Familiarity with automated inspection systems and laboratory testing processes.
• Experience with CAPA management tools and post-market surveillance processes.
• Master's degree in a related field.

Key Skills Required:

• Quality System Management (FDA QSR, ISO 13485, ISO 14971, EU MDR)
• Process Validation (IQ, OQ, PQ) and Equipment Qualification
• CAPA, Non-conformance Handling, Root Cause Analysis
• Risk Management (ISO 14971)
• Supplier Quality Audits and Management
• Data Analysis and Statistical Tools (SPC, Minitab, JMP)
• Documentation and Technical Writing
• Audits (Internal and External) and Regulatory Compliance
• Lean Manufacturing, Six Sigma, Continuous Improvement
• Quality Management Systems (TrackWise, MasterControl, Agile PLM)