Quality Engineer II ( 1st & 2nd shift)

• Develop, modify, apply, and maintain quality standards for processes and products.
  
• Collaborate with engineering and manufacturing functions to ensure quality standards are implemented and maintained.
  
• Design and implement methods and procedures for inspecting, testing, and evaluating products and production equipment.
  
• Perform statistical analysis to identify trends in defects/rejects and support decision-making.
  
• Ensure all documentation is compliant with regulatory and company requirements.
  
• Conduct and/or review validation activities (URS, FAT, IQ, OQ, PQ, TMV – excluding laboratory and cleaning processes).
  
• Investigate and collaborate in atypical events and CAPA to support product disposition.
  
• Develop and update PFMEA, Control Plans, and Process Flows.
  
• Support projects involving design requirements validation and manufacturing controls (not Operational Excellence).
  

Requirements

• Minimum 5 years of experience in the medical device/regulated industry (excluding laboratory micro/chemistry).
  
• Bachelor Degree in Engineering completed.
  
• Investigation and root cause analysis skills.
  
• Strong technical writing, organizational, and communication skills.
  
• Experience with risk management documentation (pFMEAs).
  
• Knowledge in medical device regulations (FDA, EU MDR).
  
• Basic knowledge in statistics (preferably with Minitab).
  
• Experience in process validation and equipment documents: URS, FAT, IQ, OQ, PQ, TMV.
  
• Experience investigating and assessing manufacturing operations and defects/rejects trends.
  
• Ability to apply statistical techniques, develop/review/approve test plans and reports.
  

Nice to Have:

• 1–3 years of additional medical device industry experience.
  

• Familiarity with FDA 21 CFR Part 820, EU 2017/745 (EU MDR).
  

• Knowledge of standards: ISO 13485, ISO 14971, IEC 60601.
  

• Strong proficiency in Microsoft Office (Word, Excel, Access, PowerPoint) and Windows OS.
  

• Strong interpersonal skills and ability to work cooperatively as part of a cross-functional team.
  

Top 3 Candidate Qualities

1. CAPA / Investigations / Root Cause Analyses / Technical Writing.
   

2. Risk Management (PFMEA) / Critical Thinking.
   

3. Process & Computer System Validations (excluding cleaning processes).