Manufacturing Quality Engineer

Job Title: Quality Engineer

Location: Fall River, MA

Employment Type: Full-Time

Position Summary

The Quality Engineer is responsible for developing, implementing, and optimizing quality processes to ensure compliance with ISO 13485 and business objectives. This role involves collaborating with cross-functional teams to drive continuous improvement, maintain process efficiency, and support customer requirements.

Key Responsibilities

• Develop and implement quality policies, procedures, and compliance with ISO 13485.
• Define and analyze key performance indicators for process compliance and improvement.
• Establish inspection requirements and evaluate process quality parameters.
• Conduct root cause analysis, corrective actions, and risk assessments (PFMEA).
• Lead process validation (IQ, OQ, PQ) and ensure regulatory compliance.
• Optimize production quality and efficiency, recommending new equipment as needed.
• Maintain proper documentation for production, maintenance, and quality procedures.
• Conduct process capability studies, statistical analysis, and continuous improvement initiatives (Lean, Six Sigma).
  
  

Required Skills & Qualifications

• 5 years of quality engineering experience in a manufacturing environment.
• Experience with electropolishing, electroplating, or anodizing preferred.
• Strong knowledge of ISO 9001, ISO 13485, ASTM B912, ASTM A967.
• Proficiency in SPC, data analysis, and software like Minitab.
• Strong problem-solving, project management, and communication skills.
• Ability to troubleshoot equipment issues (rectifiers, pumps, filters).
• BS in Chemical Engineering, Materials Science, or related field preferred.
• Certifications in Six Sigma or Lean Manufacturing are a plus.
  
  

Physical & Work Environment

• Ability to lift up to 30 lbs (frequently) and 50 lbs (occasionally).
• Exposure to chemicals, fumes, and moderate noise levels in a manufacturing setting.
  
  

Skills: chemicals,quality engineering,manufacturing,minitab,lean,compliance,anodizing,process validation,iso,continuous improvement,astm,spc,data analysis,electropolishing,six sigma,iso 13485,electroplating,root cause analysis,chemical engineering