Quality Specialist

About the Role We are seeking a detail-oriented and proactive Quality Specialist to join our team.

In this role, you will serve as a key interface between Sales/Marketing, R&D, and Quality, ensuring that customer specifications are accurately translated into internal documentation and quality systems.

You will also manage document control processes, support audits, and play an important role in maintaining compliance with ISO and FDA standards.

Key Responsibilities Initiate and maintain item masters, specification numbers, and related documentation in QAD.

Lead and facilitate weekly specification review meetings to ensure timely implementation.

Interface directly with customers to obtain specification approvals when needed.

Administer document change control and electronic document management systems (EQMS). Support R&D trials as the Quality representative.

Conduct vision system evaluations, including data review and final disposition.

Update and maintain bills of materials, wind-ups, and blender sheets.

Participate in customer complaint investigations, internal audits, and customer audits.

Coordinate updates to manufacturing/quality documents and manage document formats.

Support annual cost roll-up activities in collaboration with Finance.

Provide backup support for in-process inspection within Quality Control.

Qualifications Associate degree or equivalent work experience required; Bachelor’s degree preferred.

Strong written and verbal communication skills, with ability to interact professionally with customers.

Experience in an ISO 9001, ISO 15378 (FDA is a plus) Previous internal audit experience or training a plus.

Familiarity with regulatory compliance for medical formulations and/or devices desirable.

Proficiency with computer systems, electronic document management tools, and statistical applications.

Strong attention to detail and organizational skills; able to manage multiple tasks effectively.

Competencies Team player with ability to work cross-functionally and contribute creative solutions.

Understanding of quality management systems, policies, and procedures.

Ability to read, write, and communicate effectively in English.

Strong reasoning, mathematics, and problem-solving skills.

About the Company Our client is a Global Manufacturer with over 30 locations worldwide.

They are highly innovative and manufacture a wide range of plastic films and plastic products, for various markets and applications, including the automotive, medical & pharmaceutical, home & building, shipping, advertising & packaging sectors.

Together with their customers and partners, they are making vital contributions to human health in many areas of the healthcare.

industry.

Full-Time