Quality Engineer

Prentke Romich Company; Wooster (OH); Presencial; USD 75 000 - 100 000; Tempo integral

Resumo da oferta

Prentke Romich Company seeks a Quality Engineer to support quality systems across design, development, manufacturing, and post-market stages for Class II medical devices and SaMD. You will investigate issues, implement CAPAs, and drive risk management and regulatory compliance with cross-functional teams.

You’ll develop procedures, verify designs, and help improve supplier quality and product transfers, enabling reliable, compliant products that positively impact users.

Qualificações

• Bachelor’s degree in Engineering, Physical Science, Business, or a related technical field required.
• Minimum of 5 years of quality or manufacturing engineering experience in a regulated environment such as medical device, pharmaceutical, biotech, food, aerospace, or automotive industries.

Responsabilidades

• Supports quality systems, regulatory compliance activities, and continuous improvement initiatives.
• Develops and maintains quality procedures, work instructions, specifications, and training materials.
• Reviews and approves design, product, process, and engineering documentation.
• Investigates nonconformances, supplier issues, complaints, and CAPAs using root cause analysis techniques.
• Performs testing, validation activities, data analysis, and reporting to support product quality and compliance.
• Supports design verification and validation activities and product transfers from engineering to manufacturing.
• Develops inspection plans, test methods, and statistical approaches to ensure product and process conformity.
• Partners with suppliers and internal teams to improve product quality and manufacturing processes.
• Assists with complaint investigations, quality event management, change control, and risk assessment activities.
• Participates in audits, regulatory inspections, and quality system improvement efforts.

Conhecimentos

Problem solving

Statistical methods

Continuous improvement

Root cause analysis

FMEA

Control charts

DMAIC

PDCA

5S

Kaizen

Formação académica

Bachelor’s degree in a technical field

Ferramentas

FMEA

Control charts

Descrição da oferta de emprego

Help Ensure Product Quality and Compliance – Join PRC-Saltillo as a Quality Engineer!

This position is where quality, innovation, and continuous improvement come together! Are you an experienced quality professional who enjoys solving problems, improving processes, and collaborating across teams to deliver high-quality products? Bring your expertise to a mission-driven organization that develops technology that makes a difference.

The Quality Engineer provides quality support throughout the product lifecycle, including design, development, manufacturing, and ongoing improvement of Class II medical devices and software as a medical device (SaMD). This role partners with cross-functional teams to support quality systems, design controls, risk management, supplier quality, complaint investigations, regulatory compliance, and continuous improvement initiatives.

Why You’ll Love Working Here

• Mission-Driven Work: Help ensure the quality and reliability of technology that positively impacts lives.
• Meaningful Impact: Play a key role in product quality, regulatory compliance, and continuous improvement.
• Collaborative Environment: Partner with engineering, manufacturing, procurement, and regulatory teams.
• Professional Growth: Expand your expertise in medical device quality systems, design controls, and regulatory requirements.

Duties and Responsibilities

• Supports quality systems, regulatory compliance activities, and continuous improvement initiatives.
• Develops and maintains quality procedures, work instructions, specifications, and training materials.
• Reviews and approves design, product, process, and engineering documentation.
• Investigates nonconformances, supplier issues, complaints, and CAPAs using root cause analysis techniques.
• Performs testing, validation activities, data analysis, and reporting to support product quality and compliance.
• Supports design verification and validation activities and product transfers from engineering to manufacturing.
• Develops inspection plans, test methods, and statistical approaches to ensure product and process conformity.
• Partners with suppliers and internal teams to improve product quality and manufacturing processes.
• Assists with complaint investigations, quality event management, change control, and risk assessment activities.
• Participates in audits, regulatory inspections, and quality system improvement efforts.

Education and Experience

• Bachelor’s degree in Engineering, Physical Science, Business, or a related technical field required. Equivalent combinations of education and experience may be considered.
• Minimum of 5 years of quality or manufacturing engineering experience in a regulated environment such as medical device, pharmaceutical, biotech, food, aerospace, or automotive industries.

Required Skills/Abilities

• Strong problem-solving, troubleshooting, and decision-making abilities.
• Knowledge of quality engineering principles, statistical methods, and continuous improvement tools.
• Experience with root cause analysis, FMEA, control charts, DMAIC, PDCA, 5S, and Kaizen methodologies.
• Understanding of software and electronic design processes and basic electronic test equipment.
• Strong verbal, written, presentation, and facilitation skills.
• Ability to work independently and collaboratively in a cross-functional environment.
• Strong attention to detail with the ability to analyze complex technical information.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
• Flexible and adaptable in a fast-paced, changing environment.