Quality Engineer - Medical Manufacturing

Technimark; Latrobe (Westmoreland County); Presencial; USD 75.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) match

PTO / Holidays

Holiday pay

Climate-controlled facility

Life insurance

Career growth in manufacturing

Descripción de la vacante

Technimark in Latrobe, PA is seeking a Quality Engineer focused on medical manufacturing. You’ll drive validation planning, risk management, and cross-functional problem solving, ensuring products meet stringent quality and regulatory requirements.

Responsibilities include IQ/OQ/PQ validation, FMEA/risk assessments, root-cause investigations, and robust use of quality tools to support new product development and production across the organization.

Formación

• College degree or 4+ years of Quality Engineering experience.
• GMP and ISO 13485 experience highly desired.
• Experience or knowledge of quality engineering principles and quality tools.
• Experience with or understanding of validation activities and IQ/OQ/PQ methodology.
• Knowledge of FMEA and risk assessment methods.
• Ability to perform data analysis and problem solving using quality tools.
• Strong analytical, organizational, and communication skills.
• Ability to work effectively with internal and external customers and cross-functional teams.
• Understanding of manufacturing safety practices.
• Strong attention to detail and commitment to quality documentation.

Responsabilidades

• Evaluate specifications, requirements, and design documents and provide timely, valuable feedback to internal and external customers.
• Develop detailed, well-structured validation plans using IQ/OQ/PQ methodology.
• Estimate, prioritize, plan, and coordinate validation activities to ensure compliance with regulatory, internal, and customer requirements.
• Ensure validation documentation is complete, accurate, and compliant with established requirements.
• Lead or support FMEA and risk assessment activities with internal and external teams.
• Support root-cause investigations for non-conformances and contribute to effective corrective actions.
• Apply quality tools, data analysis, and structured problem-solving techniques to identify opportunities for continuous improvement.
• Partner with engineering, manufacturing, and other cross-functional teams to support new product development and production, ensuring products consistently meet customer expectations.

Conocimientos

Quality engineering

Data analysis

Problem solving

Cross-functional collaboration

Regulatory compliance

FMEA

Educación

Bachelor's degree or equivalent

Descripción del empleo

Quality Engineer - Medical Manufacturing

Job Category: Indirect Labor - Fixed

Requisition Number: QUALI003250

• Full-Time


• On-site

Locations

Showing 1 location

Latrobe, PA 15650, USA

What You’ll Do

As a Quality Engineer, you’ll play a key role in validation, risk management, problem solving, and new product development. You will:

• Evaluate specifications, requirements, and design documents and provide timely, valuable feedback to internal and external customers.


• Develop detailed, well-structured validation plans usingIQ/OQ/PQmethodology.


• Estimate, prioritize, plan, and coordinate validation activities to ensure compliance with regulatory, internal, and customer requirements.


• Ensure validation documentation is complete, accurate, and compliant with established requirements.


• Lead or supportFMEA and risk assessmentactivities with internal and external teams.


• Support root-cause investigations for non-conformances and contribute to effective corrective actions.


• Apply quality tools, data analysis, and structured problem-solving techniques to identify opportunities for continuous improvement.


• Partner with engineering, manufacturing, and other cross-functional teams to supportnew product development and production, ensuring products consistently meet customer expectations.

What You Bring

We're looking for someone who combines strong analytical thinking with a practical, collaborative approach to quality.

Required qualifications:

• College degreeor 4+ years of Quality Engineering experience.


• Previous GMP and ISO 13485 experience highly desired


• Experience or knowledge ofquality engineering principles and quality tools.


• Experience with or understanding ofvalidation activities and IQ/OQ/PQ methodology.


• Knowledge ofFMEA and risk assessmentmethods.


• Ability to performdata analysis and problem solvingusing quality tools.


• Strong analytical, organizational, and communication skills.


• Ability to work effectively withinternal and external customers and cross-functional teams.


• Understanding ofmanufacturing safetypractices.


• Strong attention to detail and commitment to quality documentation.


• 401(k) with company match


• Paid time off (PTO), sick time, and birthday holiday


• Holiday pay


• Climate-controlled manufacturing facility


• Employer-paid life insurance


• Career growth in themanufacturing industry

Why This Role Matters

Quality Engineering is more than documentation and compliance - it's about preventing problems, improving processes, and delivering products customers can trust. In this role, you’ll have the opportunity to influence products and processes from development through production while working with teams across the organization.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.