Company Site
Quality Engineer
PRC-Saltillo
Wooster, USA
Full-time
Mid · 5+ years experience
Onsite
Discovered 1 months ago
Full Job Posting
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.
About PRC-Saltillo
Electronics Manufacturing210 employeesFounded 1966
Employee-owned AAC technology company making speech-generating devices and communication apps for people with complex communication disorders.
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