JOB TITLE:

Quality Coordinator – Breda, The Netherlands

LOCATION

Breda, The Netherlands

ABOUT US:

Cold Chain Technologies (CCT) is a leading manufacturer and provider of thermal packaging solutions to the pharmaceutical, biotech, health care and medical device industries. We are a technically advanced, financially secure company with more than 50 years of experience and a history of vigorous growth.

CCT is ISO 9001 registered and is headquartered in Franklin, MA with a global manufacturing and distribution network including facilities in The Netherlands, MA, TN, NV, PA, IL, and a larger global footprint in EMEA and LATAM. Our affiliated design and testing laboratories are highly recognized throughout the industry as world-class.

JOB DESCRIPTION:

The Quality Coordinator reports functionally to the Sr. VP Global Quality & Regulatory Affairs and in the region to the Breda Site Leader. The Quality Assurance Coordinator II provides support to operations in meeting key performance metrics. Serves as decision maker on the production floor. Overall responsibilities include maintenance of the quality system documentation, in-process and final inspections, supplier quality assurance, incoming material inspection, internal audits, trend analysis reporting, and special projects. The position requires knowledge of commonly used concepts, practices and procedures within the field and relies on a certain degree of experience and judgment to plan and accomplish tasks.

PRIMARY RESPONSIBILITIES:

Carry out quality audits of the production areas as required to ensure procedural compliance and continuously improve quality performance.

Support 3rd party and customer audits for the CCT site.

Perform incoming inspections to ensure defect-free material flow.

Prepare Certificates of Compliance (COCs)

Conduct internal audits of the quality management system when assigned.

Prepare trend charts for key quality metrics and assist in responding to negative trends.

Conduct First Article Inspections

Interface with external customers and suppliers on quality-related issues.

Identify supplier quality non-conformances, issue, and track Supplier Corrective Action Requests (SCARs).

Manage supplier performance through DMR.

Provide input to customer complaint investigations.

Support problem solving and continuous improvement projects utilizing Lean/Six Sigma tools and methodologies.

Evaluate the effectiveness of implemented corrective action plans.

Ensure full compliance with all documentation related to the quality management system and define opportunities to simplify and standardize across multiple sites.

Actively support EH&S Rules and regulations.

Other duties and responsibilities as assigned

QUALIFICATIONS:

Associate degree with at least 5 years of experience in a manufacturing environment.

Working knowledge of Quality Management System standards (i.e., ISO 9001:2015, AS9100, IATF 16949).

Must be fluent in English both orally and in writing.

Must have previous experience working in a quality role in the European Union.

Experience in a cGMP environment

Ability to accurately measure materials using standard metrology equipment.

Problem solving experience

Proficient with Microsoft Word, Excel, Access

Experience working with a manufacturing ERP SW application.

Proven experience working remote from corporate function.

Skilled problem solver, specifically related to customer and 3rd party audit findings.

Ability to quicky adapt to changing priorities and customer requirements

Ability to multitask and work with associates at all levels of the organization (up, down and across the organization).

Excellent verbal and written communication skills.

Proficiency or fluency in another European language would be an advantage, e.g Spanish

Must have the right to live and work in the EU

PREFERRED QUALIFICATIONS:

Bachelor’s degree with at proven experience in quality assurance.

Proven Quality System auditing experience

Six Sigma Green Belt would be an advantage

Experience with Quality Management System Software (MasterControl)

Proven experience working directly with customers.

Proven experience working directly with suppliers.

Advance knowledge and skills using Microsoft Office suite (Word, Excel, Access, PowerPoint)