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Quality Engineer - P1 at Boston Scientific Corporation Malaysia

Cork, Munster, Ireland -

Full Time

Start Date

Immediate

Expiry Date

13 Jan, 26

Salary

0.0

Posted On

15 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Systems, Risk Management, Post Market Surveillance, Interpersonal Skills, Communication Skills, Leadership Abilities, Design Control, Complaints Investigation, CAPAs, Regulatory Compliance, Manufacturing Environment, GMP Regulations, Medical Device Industry, Product Development, Process Quality, Technical Input

Industry

Medical Equipment Manufacturing

Description

General Completes work assignments under limited supervision/guidance. Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input. Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance. Seeks to support improvements in product and process quality. Builds Quality into all aspects of work by maintaining compliance to all quality requirements. Excellent interpersonal and communication skills with good leadership abilities. Provides both quality and technical input to ongoing product development, product sustaining and post-market commercial product activities. Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, and regulatory requirement changes. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data. Experienced in post-market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements). Minimum of Bachelor of Science Degree Level 8 in Engineering/Technology. 2/3 years' experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated). Experience in the medical device industry is an advantage.

Responsibilities

The Quality Engineer will provide technical and quality systems input while interfacing with various teams. They will support improvements in product and process quality and provide design quality support in resolving complaints and regulatory changes.