Quality Operations Team Leader

onsibility for Quality Control, Final release of goods to be shipped, Calibration & Maintenance management, non-conforming products, TCA Process, Process Validation/ Verification, Operations production stabilization and improvements. Support design transfer process, PFMEA process, Customer complaints, CSA/ UL compliance

Responsibilities:

• Lead the quality operations activities such as calibration, PM, QC & Final release, nonconforming management etc

• Ensure high quality of BWI products, full compliance of products with relevant standards and specifications.

• Manages Qualification and leads validation of manufacturing processes, including Suppliers guidance with Biosense process validation requirements, planning, execution, monitoring, reporting and approval.

• Employ statistical methodologies to support process validation analysis and decision making

• Mentors and trains team members: Directs and guides team members to maximize their personal talents and to develop new skills.

• Subcontractors/ Suppliers Quality evaluation, monitoring and improvement activities.

Qualifications

• At least 3 years of experience in QA field in medical device industry

• BSc in Engineering/ BA degree or Practical Engineering with Qualification in Quality Assurance (CQE).

• Experience with Quality Audits, Quality assurance in manufacturing processes and data statistical analysis.

• Experience in leading multi-disciplinary projects

• Demonstrated knowledge of manufacturing process principles, practices, and procedures

• High Knowledge with quality processes and ability to convert them to company procedures

• Good communication and presentation skills, both verbal and written in English.

• Training/education methodologies, people leadership, talent development

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