Quality Engineer - Medical Manufacturing

Quality Engineer - Medical Manufacturing

Job Category: Indirect Labor - Fixed

Requisition Number: QUALI
003250

• Full-Time
• On-site

Showing 1 location

Latrobe, PA 15650, USA

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 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.

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

Required qualifications:

• College degree
  or 4+ years of Quality Engineering experience
  .
• Previous 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.
• 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 the
  manufacturing industry

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.