We are seeking a Manufacturing Quality Engineer with strong experience in medical device manufacturing and injection molding processes. The ideal candidate will be responsible for ensuring product quality, process compliance, validation activities, and continuous improvement initiatives within a regulated medical device environment.
Key Responsibilities
Support manufacturing quality activities for injection molded medical device components and assemblies.
Develop, implement, and maintain quality systems in compliance with FDA 21 CFR Part 820, ISO 13485, and GMP requirements.
Lead and support investigations related to non-conformances, CAPAs, deviations, and customer complaints.
Conduct root cause analysis using quality tools such as 5 Whys, Fishbone, FMEA, and Statistical Analysis.
Review and approve validation documentation including:
IQ (Installation Qualification)
OQ (Operational Qualification)
PQ (Performance Qualification)
Collaborate with Manufacturing, Engineering, Supplier Quality, and Regulatory teams to resolve quality issues.
Support process monitoring and continuous improvement initiatives for injection molding operations.
Analyze SPC data and manufacturing trends to identify opportunities for process improvements.
Participate in internal and external audits and support regulatory inspections.
Ensure compliance with change control processes and risk management activities.
Required Qualifications
Bachelor's degree in Engineering, Quality, Manufacturing, or related discipline.
3+ years of Quality Engineering experience in the Medical Device industry.