Quality Manufacturing Engineer — CAPA & PFMEA Leader

Philips International; Murrysville (Westmoreland County); On-site; USD 92,000 - 128,000; Full time

Job summary

Philips is seeking a Quality Manufacturing Engineer to drive high-quality performance in manufacturing environments. Role involves monitoring, improvement programs, PFMEA impact assessments, and CAPA leadership to ensure compliant processes.

Requirements include a Bachelor's/Master's in a relevant field and 3+ years in Quality/Process Engineering, with preference for medical device regulatory experience and data analysis capabilities.

Qualifications

• Bachelor's or Master's in Mechanical/ Electronics/ Science or equivalent.
• 3+ years of experience in Quality Engineering, Safety/Process Engineering or equivalent.
• Preference for experience with medical device regulations and standards, Process Quality Management, CAPA, Root Cause Analysis and Data Analysis.

Responsibilities

• Facilitates operations performance monitoring, reporting, improvement and development in factory settings.
• Assesses PFMEA impact and related controls for design changes; assists in MFG Process Development and Design Transfer.
• Leads analysis of defects for disposition of non-conformances; drives NC and QN management; facilitates CAPA actions.
• Ensures quality systems in manufacturing are maintained; handles process validation and improvements; supports NPI and product transfers.
• Leads validation protocols and production builds to support validation activities; analyzes data for reports and process improvements.

Skills

Quality Engineering

CAPA

PFMEA

Data Analysis

Root Cause Analysis

Education

Bachelor's/Master's in Mechanical Engineering, Electronics Engineering or Science

Job description

Philips is seeking a Quality Manufacturing Engineer to drive high-quality performance in manufacturing environments. Role involves monitoring, improvement programs, PFMEA impact assessments, and CAPA leadership to ensure compliant processes.

Requirements include a Bachelor's/Master's in a relevant field and 3+ years in Quality/Process Engineering, with preference for medical device regulatory experience and data analysis capabilities.