Quality Assurance Team Lead

We are looking for a Supplier Quality Team Leader to join our team.

Description:

o Responsible for quality activities through product manufacturing and Supply Chain processes by keeping a high level of product quality, and maintaining quality system comprehensive compliance throughout the product life cycle:

• Ensures full compliance of products with relevant standards and specifications.
• Lead related Process validation/verification activities including Suppliers' guidance with Biosense process validation requirements, planning, execution, monitoring, reporting, and approval.
• Manages Non-conformance methodology, periodical meetings, investigation, and approval throughout the entire product lifecycle from subcontractors/suppliers, HTC production process to installation and service activities.
• Support robust key production processes (CTXs cascading, monitoring tools, PFMEA Activities reduce human error etc.)
• Deploy statistical data analysis to manufacturing processes/stations.
• Promotes GMP methodology and supports continuous improvement of manufacturing processes and Reduction of non-quality costs.

o Responsible for supplier oversee from qualifying, monitoring, and improving supplier’s performance:

• Leads selection approval, auditing, qualification of suppliers and subcontractors, and maintaining ASL.
• Supplier Quality Management and Control: Evaluation and improvement based on Quality Audits, technical Assessments, nonconformances, and Corrective Actions (SCAR).

o Managing a team of Quality Engineers, mentoring and training team members.

Requirements:

• BSc in engineering / BA in Quality Assurance/ Practical Engineer Diploma.

• Qualification in Quality Assurance (CQE, CQM or CQA) – advantage.

• At least 5 years of experience in the QA field in the medical device industry.

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

• Experience in leading multi-disciplinary projects and team management.

• Demonstrated knowledge of manufacturing principles practices, and procedures.

• High Knowledge of quality processes and the ability to convert them into company procedures.

• Verbal and written communication skills (also in English), and presentation skills.

• Project management, problem solving, Leading multidisciplinary projects and processes, Good sense of urgency.

• Training/education methodologies, people leadership, talent development.

• Understanding of drawings, specifications, and electrical schemes – advantage.

Comments:

Employment by an outsource company.

Temporary position - maternity leave replacement.

Biosense Webster is an equal opportunity working place promoting diversity and inclusion in the workplace.

This position may be suitable for any person subject to their qualifications and capabilities, regardless of (inter alia) gender, origin, ethnicity, sexual orientation, and/or disability.