Quality Assurance Manager — ISO 9001 & UL Compliance

Aitken Pharmacy; Westminster (MA); On-site; USD 100,000 - 140,000; Full time

Job summary

Mayhew Basque Plastics seeks a Quality Manager to lead QMS, maintain ISO 9001:2015 and UL compliance across injection molding operations. You will drive continuous improvement, manage audits, and align quality initiatives with business goals.

You will train staff, manage documentation, and act as liaison for customer quality inquiries while ensuring regulatory requirements are met and customer satisfaction.

Qualifications

• Bachelor’s degree in Engineering, Quality Management, or related field.
• Minimum 5 years of experience in quality management with injection molding or manufacturing.
• ISO 9001:2015 Lead Auditor certification is preferred.

Responsibilities

• Maintain and manage the Quality Management System (QMS) in accordance with ISO 9001:2015.
• Track and analyze KPIs; diagnose substandard metrics and identify predictive trends.
• Serve as primary contact for ISO audits and certification processes.
• Investigate non-conformances, including material analysis and issuing CARs.
• Oversee new product setup in Macola ERP, including BoM and routing.
• Coordinate Product Change Requests with departments and update BoMs/work orders.
• Conduct internal audits and layered process audits for ISO prep.
• Train new employees on quality assurance programs.
• Communicate the Quality Policy and ensure understanding across the organization.
• Investigate customer complaints in collaboration with relevant departments.
• Ensure compliance with UL standards, customer specs, and regulatory requirements.

Skills

Communication skills

Team collaboration

Attention to detail

English proficiency

Education

Bachelor’s degree in Engineering/Quality Management

Tools

SPC

FMEA

CAPA

Macola ERP

Microsoft Office

Adobe

ERP systems

Job description

Mayhew Basque Plastics seeks a Quality Manager to lead QMS, maintain ISO 9001:2015 and UL compliance across injection molding operations. You will drive continuous improvement, manage audits, and align quality initiatives with business goals.

You will train staff, manage documentation, and act as liaison for customer quality inquiries while ensuring regulatory requirements are met and customer satisfaction.