On-site Quality Engineer - Medical Manufacturing

Technimark; Latrobe (Westmoreland County); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

401(k) match

PTO / Holidays

Holiday pay

Climate-controlled facility

Life insurance

Career growth in manufacturing

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality engineering

Data analysis

Problem solving

Cross-functional collaboration

Regulatory compliance

FMEA

Education

Bachelor's degree or equivalent

Job description

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.