Boston Scientific Associate Quality Manager 

Ireland 

803156003

Advancing possibilities for a brighter tomorrow

This position is for a 23 month contract

Purpose Statement

Leads team of Quality Engineers and Quality Engineering activities that directly or indirectly support production operations and new product introduction. Develops, establishes and maintains quality methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Ensures implementation of assurances, process controls, and CAPA systems designed to meet and exceed internal and external requirements.

Key Responsibilities

• Lead team of Quality Engineers to provide direction, coaching, and mentoring and provide guidance on daily work priorities and sequence of activities in area of responsibility.
• Is an effective people manager resulting in a motivated high performing team and is fully motivated to achieve and demonstrate best practices in line with departmental and Strategic Quality objectives.
• Responsible for performing performance appraisals, for all reporting staff.
• Co-ordination of staff holidays and for ensuring sufficient cover is available to support manufacturing during shut down periods.
• Responsible for ensuring the department operates within in a set budget.
• Mentor for technical guidance in identifying and resolving quality issues using six sigma, lean, mistake proofing, and related tools/techniques.
• Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
• Understands, Maintains and implements quality engineering systems and practices to meet BSC, customer and regulatory requirements.
• Serves as a quality representative for the department in all internal / external Audits as functional expert.
• Develops, maintains, and communicates metrics to drive continuous quality and efficiency through the department.
• Leads and participates in customer complaint investigations.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel as appropriate.
• Investigates, identifies, and implements best-in-class Quality Engineering practices.
• Applies effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Focuses on continuous improvement by championing value improvement projects (VIP).
• Lead audit back room and provide front room support for External audits and ensure that the Production unit is audit ready at all times.
• Coordinate and conducts technical investigation and documentation of non-conforming events and trends, and develop technical investigation plans using eCAPA and BSC Engineering Essentials.

Education & Experience

• Honours Bachelor’s degree in Engineering, Science, or related field.
• Minimum 5 years of related work experience in a Quality Engineering role within medical device manufacturing including minimum 2 years’ experience as a people leader.
• Proven experience leading cross-functional teams and managing complex quality issues.
• Strong analytical, communication, and project management skills
• Ability to work independently; organized and self-driven.
• A strong communicator (written and verbal) who can effectively organize, present and explains data/ information with all internal & external stakeholders.
• Demonstrated understanding of QSR and ISO standard requirements for medical devices.

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