Quality Engineer II at Boston Scientific Corporation Malaysia

Galway, Connacht, Ireland -

Full Time

Start Date

Immediate

Expiry Date

08 Mar, 26

Salary

0.0

Posted On

08 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, MDR Standards, QSR Standards, Validation Techniques, Risk Management, Six Sigma, Statistical Analysis, Lean Principles, Collaboration Skills, Project Management, Customer Complaints Investigation, Environmental Impact Assessment, Technical Guidance, Process Improvement, Internal Audit Processes, Medical Device Industry Knowledge

Industry

Medical Equipment Manufacturing

Description

Identifies and resolves complex exceptions to work assignments. Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings. Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product. Participates in Customer Complaints investigation for areas under their control. Continually seeks to drive improvements in product and process quality. Knowledgeable on MDR and QSR standards, constantly promoting awareness of best industry practices, making appropriate decisions daily utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions. Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints. Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects. Knowledgeable on Risk Management risk documentation linkage. Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes. May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements. Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality. Possesses excellent collaboration skills Gives technical guidance to relevant team members as required Is fully motivated to achieve and demonstrate best practices in line with the department and Site objectives. Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise. A Level 8 Honours Degree (240 Credits) in an Engineering or Science related discipline. A minimum of 5+ years' experience working at Engineering level, ideally within the Medical Device industry or another highly regulated environment. Familiar with Internal Audit Processes. Project Management experience is essential.

Responsibilities

The Quality Engineer II identifies and resolves complex exceptions to work assignments and has the authority to make decisions related to product quality. They participate in customer complaints investigations and drive improvements in product and process quality.