ISO 9001 Quality Lead | Data-Driven, Onsite in MA

Akraya; North Reading (MA); On-site; USD 76,000 - 81,000; Full time

Job summary

Akraya is seeking a Quality Assurance lead to drive the ISO 9001 certification program and oversee the development and execution of the quality management system in a hardware manufacturing environment. You will manage documentation, CAPA, and change control while coordinating cross-functional teams for successful product introductions.

The role emphasizes data-driven decision making, field quality oversight, and delivering continuous improvements through performance dashboards and regular

Qualifications

• Proven experience implementing or certifying quality management systems (ISO 9001, etc.).
• Expertise in quality methodologies like APQP, FMEA, and root cause analysis.
• Proficiency in data analysis using databases, spreadsheets, and BI tools.

Responsibilities

• Spearhead the end-to-end ISO 9001 certification process, including gap analysis, documentation, and audits.
• Establish and manage key quality system processes such as document control, CAPA, and change management.
• Oversee quality gates for new product introductions from prototype to production validation.
• Manage field quality, including failure analysis, warranty claims, and customer escalations.
• Develop and present a company-wide quality dashboard and lead weekly/monthly quality reviews.

Skills

ISO 9001 implementation

Quality management systems

Data analysis and visualization

Technical writing

Project management

Job description

Akraya is seeking a Quality Assurance lead to drive the ISO 9001 certification program and oversee the development and execution of the quality management system in a hardware manufacturing environment. You will manage documentation, CAPA, and change control while coordinating cross-functional teams for successful product introductions.

The role emphasizes data-driven decision making, field quality oversight, and delivering continuous improvements through performance dashboards and regular