Manufacturing Quality Engineer

Katalyst Healthcares & Life Sciences; Reedsville (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC seeks an experienced Manufacturing Quality Engineer to lead quality assessments, remediation, validation, and continuous improvement in a regulated medical device environment.

The role requires extensive experience with CAPA, nonconformances, process validation (IQ/OQ/PQ), and risk management, with a focus on FDA 21 CFR Part 820, ISO 13485, and PFMEA. You will collaborate across manufacturing teams to reduce defects and drive quality performance.

Qualifications

• 8+ years of medical device quality experience.
• Class II/III medical device experience.
• FDA 21 CFR Part 820/QMSR knowledge.
• ISO 13485 and ISO 14971 expertise.
• Experience with CAPA and nonconformance management.
• Strong validation experience (IQ/OQ/PQ) and TMV.

Responsibilities

• Lead manufacturing quality assessments and process audits.
• Drive FPY improvement and defect reduction.
• Review process validation activities (IQ/OQ/PQ).
• Support risk management and PFMEA activities.
• Manage CAPA, nonconformances, and supplier quality issues.
• Apply SPC, MSA, PFMEA, and quality tools.
• Support FDA, ISO 13485, and MDSAP audits and inspections.
• Drive manufacturing risk reduction and quality improvement initiatives.

Skills

Quality management

Regulatory compliance

Process improvement

Risk management

Education

Engineering degree

Tools

CAPA system

QMS

SPC

PFMEA

Job description

Summary:

Seeking an experienced Manufacturing Quality Engineer to lead quality assessments, remediation, validation, and continuous improvement within a regulated medical device manufacturing environment.

Roles & Responsibilities:

• Lead manufacturing quality assessments and process audits.
• Drive First Pass Yield (FPY) improvement and defect reduction.
• Review process validation activities, including IQ/OQ/PQ.
• Support risk management and PFMEA activities.
• Manage CAPA, nonconformances, and supplier quality issues.
• Apply SPC, MSA, TMV, and manufacturing quality tools.
• Support FDA, ISO 13485, and MDSAP audits and inspections.
• Drive manufacturing risk reduction and quality improvement initiatives.

Required Qualifications:

• 8+ years of Medical Device Manufacturing Quality experience preferred.
• Class II/III medical device experience.
• Strong process validation and TMV expertise.
• Experience with CAPA and nonconformance management.
• Knowledge of FDA 21 CFR Part 820/QMSR.
• ISO 13485 and ISO 14971 expertise.
• SPC, MSA, PFMEA, and supplier quality experience.
• Engineering bachelor's or master's degree preferred.