Quality Analyst Complaints

Venture Hire Group LLC; Carlsbad (CA); On-site; USD 41,000 - 58,000; Full time

Benefits offered by this job

Competitive hourly compensation

Job summary

Venture Hire Group LLC in Carlsbad, CA is seeking a Quality Analyst to lead complaint investigations, document findings in the quality management system, evaluate returned products, and support cross-functional teams in a medical device environment. The role requires a Bachelor's degree in a technical field and 3+ years of quality, manufacturing, or medical device experience.

Candidates must demonstrate attention to detail, strong analytical and communication skills, and proficiency with MS

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, Biomedical Engineering, or related technical discipline, or equivalent education/experience.
• 3+ years in Quality, Manufacturing, Technical Support, Product Investigation, or Medical Device environment.
• Strong attention to detail and ability to maintain accurate documentation.
• Experience investigating technical issues and documenting findings.
• Ability to manage multiple priorities while maintaining compliance and record accuracy.
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office applications and electronic quality management systems.

Responsibilities

• Manage customer complaints from receipt through final closure in the complaint handling system.
• Review complaint information for completeness and accuracy.
• Conduct thorough investigations to determine complaint causes, failure modes, and potential product impact.
• Accurately document investigation activities, findings, risk assessment conclusions, and justification for decisions.
• Ensure complaint records are maintained in compliance with applicable quality system and regulatory requirements.
• Coordinate with Engineering, Manufacturing, Clinical, Regulatory, and Customer Support teams during investigations.
• Identify and communicate adverse trends, recurring issues, and opportunities for corrective action.
• Support complaint trending and quality metric reporting activities.

Skills

Attention to detail

Strong communication skills

MS Office proficiency

Quality systems familiarity

Education

Bachelor's degree in Engineering, Life Sciences, Quality, Biomedical Engineering or related

Tools

Electronic quality management systems

MS Office

Job description

Quality Analyst (Carlsbad, CA) $30-42hr+

SNAPSHOT!

Looking to join a cutting edge medical device team that is paving the way in a very unique product line? Read on! The Quality Analyst will lead complaint investigations, document findings in the quality management system, evaluate returned products, perform troubleshooting and testing activities, and ensure all records are complete, accurate, and compliant with regulatory requirements. This position combines analytical investigation work with hands-on product evaluation and cross-functional quality support activities.

Immediate Opening for a Quality Analyst who possesses:

• Bachelor's degree in Engineering, Life Sciences, Quality, Biomedical Engineering, or related technical discipline; or equivalent combination of education and experience.
• 3+ years of experience in a Quality, Manufacturing, Technical Support, Product Investigation, or Medical Device environment.
• Strong attention to detail and demonstrated ability to maintain highly accurate documentation.
• Experience investigating technical issues and documenting findings.
• Ability to manage multiple priorities while maintaining compliance and record accuracy.
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office applications and electronic quality management systems.

Key Responsibilities include:

• Manage customer complaints from receipt through final closure in the complaint handling system.
• Review complaint information for completeness and accuracy.
• Conduct thorough investigations to determine complaint causes, failure modes, and potential product impact.
• Accurately document investigation activities, findings, risk assessment conclusions, and justification for decisions.
• Ensure complaint records are maintained in compliance with applicable quality system and regulatory requirements.
• Coordinate with Engineering, Manufacturing, Clinical, Regulatory, and Customer Support teams during investigations.
• Identify and communicate adverse trends, recurring issues, and opportunities for corrective action.
• Support complaint trending and quality metric reporting activities

Compensation Includes:

• $30-42hr DOE