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Senior Quality System Specialist - Field Action (FA) Process at Boston Scientific Corporation Malaysia
, , -
Full Time

Start Date

Immediate

Expiry Date

10 Feb, 26

Salary

0.0

Posted On

12 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Quality System Management, Field Action Execution Process, Collaboration, Cross-Functional Initiatives, Independent Work, Interpersonal Skills, Communication Skills, Influencing Skills, Decision-Making, Prioritization, Problem-Solving, Time Management, Urgency, Commitment to Execution

Industry

Medical Equipment Manufacturing

Description
Manage the EMEA Regional Field Action process execution steps in accordance with defined procedures. Collaborate with cross-functional teams (Regulatory, Quality, Customer Care) to ensure stakeholder understanding and expectations in relation to Field Action activities. Represent EMEA Quality Regional FA Team in cross-functional meetings and improvement workstreams Support the execution of EMEA FA process improvement initiatives. Communicate effectively across all levels of the organisation, tailoring messaging to audience. Influence decision-making through clear articulation of risks, trade-offs, and business impact. Assist with audits and inspections related to field action processes. Ensure timely and accurate documentation of NCEP/CAPA investigations in accordance with established procedures in relation to the Field Action Process. 5-7 years of experience in Quality System Management within the medical device or related industry. Knowledge of the Field Action execution process. Demonstrated ability to collaborate effectively in a global, matrixed organization. Experience leading cross-functional initiatives to completion. Ability to work independently, and within a team, in a dynamic environment. Strong interpersonal, communication, and influencing skills. Excellent decision-making, prioritization, problem-solving, and time management abilities. High sense of urgency and commitment to execution in a fast-paced setting.
Responsibilities
Manage the EMEA Regional Field Action process execution steps and collaborate with cross-functional teams to ensure stakeholder understanding. Support the execution of EMEA FA process improvement initiatives and assist with audits and inspections related to field action processes.