Job Description

We wish to appoint a QA/RA Manager who will report to the Plant Manager and Vice President of Quality Bausch Health.

The successful candidate will be responsible for:

- Global regulatory affairs (RA), quality assurance (QA) and quality control (QC) activities for Sterimedix manufactured devices and site activities.

- Ensuring that the quality management system is efficient, effectively implemented and ensures compliance with the requirements of the applicable regulatory agencies, standards and directives.

- Final product quality and administering customer complaints and the internal CAPA system, ensuring all feedback is driving trend analysis and risk reduction / product and process improvement.

Benefits:

• On-site parking
• Private medical/dental insurance
• Life insurance

Schedule:

• Monday to Friday

Required Knowledge, Skills, and Abilities

The successful candidate must have excellent working knowledge of: - European Medical Device Directive (MDD) - Medical Device Regulation (MDR) - ISO 13485:2016 - FDA Requirements - MDSAP - JPAL - ANVISA. Must have experience as an internal auditor and be able to administer a team of internal auditors. The ideal candidate will be a highly motivated individual with the ability to priorities a variety of tasks independently. Experience: Quality experience - Medical: 3 years (Preferred). Quality Assurance: 5 years (Required).