Boston Scientific Senior Manager Scientific Communications- ICTx 

United States, Minnesota 

188864937

Job Purpose:

To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.

Key Responsibilities:

• Be the Subject Matter Experts with regard to 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 identifies root cause.
• Be an agile team member who can support all functions required based on shift requirements.
• Complete investigation 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.
• Participate in internal quality audits.
• Trending and analysis of key Quality metrics.

Education & Experience:

• NFQ Level 6 or above in Science or Engineering Discipline.
• 2-5 Years experience in a similar position or medical device background.
• 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 & prioritising and communication skills are required for this role.

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