Quality Systems Lead

Morgan Advanced Materials • New Bedford, MA

1d • Onsite

About The Position

Morgan Advanced Materials is a business rich in history and innovation. Founded in the UK in 1856, we have grown into a global organisation with 70 sites in 18 countries. Our model to serve our customers where they need us has led to a diversified product range using our unparalleled expertise in ceramic and carbon materials, which we exploit to solve difficult problems for our customers across a diverse range of markets. We are a purpose driven organisation. Our purpose is to use advanced materials to make the world more sustainable and to improve the quality of life. We deliver on that purpose through the products that we make, and the way that we make them. The Technical Ceramics business of Morgan Advanced Materials engineers high performance functional and structural ceramic materials, components and sub-assemblies to address customer-specific technical challenges. Key Figures: Revenue £1,100.7m (2024), ~8,000 employees, manufacturing in 20+ countries, and a global customer portfolio. A UK PLC with head office located in Windsor, Berkshire UK. Listed on London Stock Exchange; Member of the FTSE 250 Index.

Requirements

• Bachelor of Science, preferably Quality Management.
• Three to five years related experience.
• Individual must be a: Citizen of the United States, or Permanent resident alien of the United States, or Protected individual as defined by 8 U.S.C. 1324b(a)(3) as defined by 22CFR120.15

Nice To Haves

• CMI Certification preferred.

Responsibilities

• Assisting Quality Manager with the implementation, management and improvement activities of the Quality System, including auditing, document control, and quality system processes/procedures required for quality system certifications such as ISO 9001, ISO 13485, ISO 14001, NADCAP and AS9100.
• Manages CAPA system, including creating and verifying CAPAs and facilitating updates. Confers with Quality representatives for departments to ensure that CAPA is complete and follow up is valid.
• Maintains logs for CAPA. Analyzes data to identify trends and areas of improvement.
• Manages internal auditing program to sustain registration to quality standards while maintaining the effectiveness of the system. Schedule, plan and perform audits per ISO 9001, ISO 14001, ISO 13485, NADCAP and AS9100. Continually updates systems based on audit results and other data driven indicators
• Responsible for coordinating and leading third party audits, including registrar surveillance audits.
• Manages pre-audit communications, surveys and requested documentation for all registrar or customer related audits.
• Supports Purchasing Department through supplier auditing.
• Performs process audits to identify weaknesses within Production process documentation and practices.
• Develop and document training/certification systems including part specific, NADCAP process specific and assist in maintaining and updating overall site training plan. Oversees and manages training record retention.
• Develops and maintains a Quality System for the validation of software including Excel sheets, off-the-shelf software packages, custom built programming/applications, etc.
• Analyze new software systems for validation needs and recommend actions to take.
• Assist in creating software validation protocols.
• Develops and updates procedures, forms and work instructions to support the Quality System.
• Manages Document Control processes including updating controlled documents, training facilitation, distribution and record retention.
• Reviews all DCO to ensure completeness and adherence to document control guidelines.
• Maintain and update documentation logs and matrices. Coordinate document retrieval from warehouse.
• Maintains company’s technical electronic library, including external specifications, standards and requested technical articles and abstracts.
• Maintains electronic files for all applicable documents and ensures access to documents in order to improve usability. Ensures that obsolete documents are maintained separate from active documents.
• Maintain Part Number Master List to cross reference Customer part number with Morgan part number
• Maintain Tooling Master List
• Ability to deal with problems involving several concrete or abstract variables and define problems, collects data, establish facts, and draw valid conclusions.
• Lead auditor training per ISO 9001 or AS9100.
• Additional job duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level