Founded in 1980 and headquartered 30 miles west of Boston, small medical device manufacturer and distributor offers an impressive and expanding line of medical specialty devices for use in ENT surgery, Respiratory Therapy and Thoracic Surgery.

The Quality Assurance (QA) Associate will be required to work independently with excellent attention to detail and a quality-improvement mindset.

The ideal candidate will be familiar with worldwide quality system requirements including FDA GMP and ISO 13485.

The QA Associate works under the guidance of the QA Manager, and will perform the following duties:

·         Help to write and maintain a quality management manual and guidelines.

·         Implementing and or enforcing routines and procedures.

·         Help to evaluate customer complaints, production control and other assigned duties.

·         Assist with the formulation and ongoing monitoring of quality control standards and objectives.

·         Assist with the creation and implementation of inspection criteria and procedures.

·         Attend and assist in all audits and ensures that all audits (internal and external) are performed, documented, reviewed, and closed.

·         Review equipment calibration, validation, and maintenance records to ensure they are performed correctly and on time. 

·         Assist in quality and safety training as assigned.

·         Review SOPs to ensure that the most recently approved SOP procedures and forms are in the center procedure manuals and in use.

·         Perform QA review of training records to ensure compliance with SOP, training manual and regulations.

·         Assist in the review and modification of different manufacturing procedures and documents as part of continuing process improvements.

·         Assist in the QA review of protocols and reports.

·         Perform activities required for investigation, implementation and effectiveness checks associated with the CAPA program as directed.

·         Work with Quality Manager to fulfill all quality requirements in their absence.

·         Performs internal audits, verifying process compliance to ISO standards.

·         Maintain files and records of department activities, documents, issues of prints, schematics, schedules, engineering changes and specifications.

·         Support the change control process through working with change owners to address change request files.

·         Support the complaint process working with the regulatory team to review, assess and close complaint files. 

·         Assist in the preparation of information for Management Reviews, Internal and Vendor Audits, Complaint Investigations, and Corrective Actions

·         Provide support in FDA inspections, ISO Certification and surveillance audits and customer audits.

·         Perform other related duties as required.

Candidates must possess excellent written and oral communication skills and be proficient in Microsoft Windows and Office software.

We offer a competitive compensation structure and a comprehensive benefits package.