The Quality Assurance Coordinator plays an important role to ensure compliance through the development, implementation, and maintenance of the Business Unit’s Quality System.

This includes electronic and paper-based methods for document control, training, change management, nonconformances, corrective and preventative actions, complaints, and Risk Management.

Additionally, this position upholds the Quality Objectives and KPIs for Calibre Scientific at the Business Unit Level.

Responsibilities

• Review production batch records to ensure that products meet release specifications.
• Review, prepare, execute, approve, assist with, and maintain applicable Quality System elements.
• Support integration of current and future acquisitions and maintenance of the Quality System into an electronic QMS.
• Work cross-functionally to share ideas and drive continuous improvement activities.
• Collaboratively negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy through technical support, as needed (e.

g., Customer complaints / feedback).

• Evaluate monthly trending reports and metrics, as required to support the visibility of the health of the quality management system.
• Accountability for Quality System responsibilities (initiate, evaluate / investigate, approve, and retain) which include related Nonconformances, Corrective Action, Preventative Action, Document Control, Change Control, Risk management, Supplier Quality, etc.
• Support regulatory authorities’ and ISO certification audits.
• Update and maintain documentation, as required to ensure quality compliance.
• Contribute and lead projects and improvements from Corporate to Business Unit Levels
• Support Business Unit processes and projects as agreed with Quality Management and the BU’s Site Manager.
• Additional responsibilities as required by management.

Qualifications

Education / Experience :

Bachelor's degree from four-year college or university; or one to two years related experience and / or training; or equivalent combination of education and experience.

Experience within a Medical Device company or ISO 9001 / 13485 certified company preferred.

Language Ability :

Read, analyze and interpret scientific and technical journals, financial reports and legal documents. Respond to inquiries or complaints from customers, agencies or members of the business community.

Write speeches and articles for publication. Working knowledge of / Fluency in the English language (spoken and written).

Mathematical Ability :

Add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Compute rate, ratio and percent, and draw and interpret bar graphs.

Reasoning Ability :

Define problems, collect data, establish facts and draw valid conclusions. Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills :

To perform this job successfully, an individual should have knowledge of

• Intermediate to expert level use of Microsoft Applications (e.g., Word, Excel, PowerPoint, Outlook)
• Experience with electronic Quality Management Systems preferred.

Certificates and Licenses :

• None required.
• A Certified auditor or other Quality Certification is a bonus.
1 day ago