To provide expert QA support to Operations, ensuring operational goals and objectives are achieved for the plant.
Key Responsibilities Be the Subject Matter Expert regarding Acceptable Quality Standards for products and processes.
Ensure Regulatory compliance in area to cGMP's of all medical device regulatory agencies (e.g.
FDA and TUV).Represent QA as the first point of contact for daily line support issues.
Troubleshoot product and process-related issues and identify root causes.
Be an agile team member who can support all functions as required based on shift requirements.
Complete investigation and analysis of customer complaints.
Work with QE's and product teams to identify areas for risk reduction and error-proofing processes and work on implementation of these.
Drive Defect awareness training with product builders with the assistance of the manufacturing trainer.
MRB:
Provide disposition for any non-conforming product and identify appropriate corrective action with other support team members.
Perform internal quality audits.
Trend and analyze key Quality metrics.
Support automated lines and processes with respect to all potential issues.
Education & Experience NFQ Level 6 or above in Science or Engineering Discipline.
Decision-making ability coupled with the ability to work on one's own initiative and with minimum supervision is required.
Learning ability, to learn an automated process and be comfortable to support on shift as required.
Good interpersonal, planning & prioritizing, and communication skills are required for this role.
Boston Scientific is an Equal Opportunity Employer.
We are committed to providing an inclusive recruitment process.
Should you require reasonable accommodation during the application or recruitment process, please email
as we are here to support you throughout your candidate journey.
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