QMS Specialist Consultant I

This position will require a candidate to be onsite 100% of the time.

Notes from the manager - I need someone who is a very quick learner. There will be formal training on the database systems we work with as well. This is a highly transactional role of entering records into databases.

Track and Enter quality audit outputs (Internal and External) into PIL tool to ensure proper storage of audit schedule, audit agenda, audit report, document list, etc.

Draft audit reports for lead auditors and audit teams

Managing External Audit data to ensure external audit reports and findings are recorded in PIL solution

Support the audit BPO/BPE with updating qualification data in PIL tool

Review audit package for accuracy

Positively interact with various internal compliance members

Provide data queries and reports from the PIL tool as request/required by management and/or process

Responsible for generating audit engagement in PIL tool prior to each audit

Responsible for storing current audit schedule in PIL tool at regular intervals

Responsible for timely creation and processing of final audit reports to assign CAPA IDs to audit observations

Responsible for storage of audit records in PIL tool for each completed audit

Generates queries in the CAPA PIL tools or other identified tools in preparation for audits

Generates departmental metrics and reports to management

Completes work with a limited supervision

Draft audit reports for lead auditors and audit teams

Bachelor s degree, or equivalent experience

Basic experience with data analysis and research

Proficient technical writing skills

Advanced experience with data entry

1-3 years of experience in a regulated industry

1-3 years working in quality management systems and/or regulatory affairs

1-3 years of experience in a medical device industry required

Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and EU MDR