Associate Quality Manager (Defined Term) at Boston Scientific Corporation Malaysia

Cluain Meala, Munster, Ireland -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Process Controls, CAPA Systems, Six Sigma, Lean, Mistake Proofing, Analytical Skills, Communication Skills, Project Management, Problem-Solving, Continuous Improvement, Technical Guidance, Team Leadership, Regulatory Compliance, Customer Complaint Investigation, Metrics Development

Industry

Medical Equipment Manufacturing

Description

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. 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. 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 conduct technical investigation and documentation of non-conforming events and trends and develop technical investigation plans using eCAPA and BSC Engineering Essentials. Honours Bachelor's degree, level 8, in engineering, Science, or related field. Minimum 5 years of related work experience in a Quality Engineering role within medical device manufacturing including a minimum of 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.

Responsibilities

Develop and maintain quality methodologies and systems to meet regulatory requirements while leading a team of Quality Engineers. Ensure compliance with quality standards and drive continuous improvement initiatives.