Quality Assurance - QA​/QC, Quality Engineering, Regulatory Compliance Specialist

Germantown, United States | Posted on 06/21/2024

Germantown WI

Our client is seeking a detail-oriented and experienced Quality Engineer to maintain and enhance product quality standards.

Responsibilities:

• Develop and implement quality control procedures aligned with regulatory standards and customer requirements.
• Conduct quality audits and inspections to identify areas for improvement and ensure adherence to quality standards.
• Analyze quality data to identify trends, root causes, and process optimization opportunities.
• Collaborate cross-functionally to resolve quality issues, implement corrective actions, and drive process improvements.
• Provide technical expertise to ensure product quality and reliability.
• Participate in new product development projects toensure quality requirements are met.
• Maintain documentation related to quality processes, procedures, and specifications.
• Lead continuous improvement initiatives to enhance quality, reduce waste, and increase efficiency.
• Develop and review product, process, and software validation protocols.

Qualifications:

• Bachelor's degree in Engineering.
• 5+ years of quality engineering experience in manufacturing.
• Strong knowledge of quality management systems(ISO 9001, AS9100) and regulatory requirements.
• Experience with quality tools (SPC, FMEA, rootcause analysis).
• Team player with excellent interpersonal and communication skills.
• Legally authorized to work in the US without sponsorship.
• Proficiency in data analysis and statistical software.
• Excellent problem-solving skills and attention todetail.