Medical Device QA Engineer - On-Site Houston, PA

Perryman Company; Houston (PA); On-site; USD 70,000 - 100,000; Full time

Job summary

Perryman Company is seeking a Quality Engineer to support on-site manufacturing operations in Houston, PA. You will help design and implement testing policies, support quality systems, and collaborate with operations and product development.

The role emphasizes compliance with FDA QMS and ISO 13485, audits, and continuous improvement using SPC, DOE, and CAPA to ensure product quality from concept to market.

Qualifications

• Bachelor's degree in Engineering or related industrial, scientific, or business field required.
• 2-5 years’ experience in a quality role within a regulated industry, with increasing responsibility preferred.
• Experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility preferred.
• Experience with FDA and ISO 13485 accreditation inspections is a plus.
• Must be adept in use of computer software for the analysis of data, preferably Microsoft Excel and statistical packages (Minitab preferred).
• Quality Engineering certification (CQE) preferred or equivalent knowledge in areas including Statistics, SPC, GD&T; DOE; etc.

Responsibilities

• Maintain company compliance with FDA Quality Management System Regulations and ISO 13485 standards.
• Draft and execute protocols for IQ, OQ, and PQ initiatives relating to new products, new procedures, and process changes.
• Participate in internal, customer and third party audits, and other activities covered under Perryman’s Quality Manual, Policies and Procedures.
• Support quality inspectors for production and new products.
• Provide customer-related quality and regulatory inquiry support.
• Lead and provide Project Management support as needed.
• Lead disposition of discrepant material and devises processes to minimize recurrence.
• Lead CAPA investigations, 8D root cause analysis, and implementation of corrective and preventive actions.

Skills

Quality engineering

FDA/ISO 13485 experience

Statistical analysis

Minitab

CAPA

GD&T

Six Sigma

Project management

Education

Bachelors degree in Engineering

Tools

Minitab

Job description

Perryman Company is seeking a Quality Engineer to support on-site manufacturing operations in Houston, PA. You will help design and implement testing policies, support quality systems, and collaborate with operations and product development.

The role emphasizes compliance with FDA QMS and ISO 13485, audits, and continuous improvement using SPC, DOE, and CAPA to ensure product quality from concept to market.