Quality Manager

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

Position Type: Full‑Time Monday‑Friday 8:00 am – 4:30 pm Department: Manufacturing

Reports To: Operations Manager Direct Reports: Quality Inspectors Coordinates With: All Departments

Position Overview

Mayhew Basque Plastics is seeking a strategic and experienced Quality Manager to lead our quality assurance and compliance efforts across injection molding operations. This role is responsible for overseeing the Quality Management System (QMS), maintaining ISO 9001:2015 certification, ensuring UL compliance, driving continuous improvement, and aligning quality initiatives with business goals. The Quality Manager will serve as a key leader in shaping our quality culture and ensuring customer satisfaction.

Job Characteristics

• Maintain and manage all aspects of the Quality Management System (QMS) in accordance with ISO 9001:2015.
• Track and analyze Key Performance Indicators (KPIs); diagnose substandard metrics and identify predictive trends.
• Manage and record changes to QMS forms and procedures; ensure documentation retention.
• Serve as the primary point of contact for ISO audits and certification processes.
• Investigate product non‑conformances, including material analysis and issuing Corrective Action Requests (CARs).
• Oversee new product setup in Macola ERP, including product definition, BoM, and routing.
• Coordinate Product Change Requests with affected departments and oversee updates to BoMs, work orders, etc.
• Conduct Documented Internal Audits and Layered Process Audits across departments in preparation for ISO audits.
• Train all new employees on quality assurance programs and initiatives.
• Communicate the Quality Policy across the organization and verify understanding.
• Issue retraining notices when necessary based on audit findings or customer complaints.
• Investigate customer complaints in collaboration with relevant departments.
• Ensure compliance with UL standards, customer specifications, and regulatory requirements.
• Serve as the primary liaison for customer quality inquiries and audits.

Required Skills & Qualifications

• Proven experience with ISO 9001:2015 and UL compliance.
• Strong technical, engineering, and manufacturing background.
• Proficiency in quality tools (SPC, FMEA, CAPA) and statistical/data analysis techniques.
• Excellent communication skills across all organizational levels.
• Proficiency in Microsoft Office, Adobe, and ERP systems.
• Strong attention to detail in a fast‑paced environment.
• Written and verbal English communication skills.
• Team‑oriented with a commitment to company goals.
• Willingness to maintain a clean and safe work environment.
• Adherence to company attendance policy.
• ISO 9001:2015 Lead Auditor certification.

Required Education/Experience

• Bachelor’s degree in Engineering, Quality Management, or related field.
• Minimum 5 years of experience in quality management with injection molding or manufacturing.

Preferred Education/Experience

• CQE (Certified Quality Engineer) or equitable level of experience and qualifications
• ASQ (American Society for Quality) certifications or equitable level of experience
• Familiarity with metallurgy or tool manufacturing

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Although this position is primarily a seated at a desk position an employee performing the duties of this job may occasionally be required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; stoop, kneel, or crouch; talk or hear. Visual focus is often required. The employee must occasionally lift and/or move up to 50 pounds.