Quality Engineer - P2 at Boston Scientific Corporation Malaysia

The Municipal District of Newcastle West, Munster, Ireland -

Full Time

Start Date

Immediate

Expiry Date

13 Feb, 26

Salary

0.0

Posted On

15 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Risk Mitigation, cGMP Compliance, Validation Requirements, Process Improvements, Statistical Techniques, Lean Manufacturing, Medical Device Industry, Failure Mode Analysis, Customer Complaint Analysis, Regulatory Documentation, Process Automation, Master Validation Plans, Error Proofing, Sampling Techniques, DOE Studies

Industry

Medical Equipment Manufacturing

Description

Provide effective and responsive QA support on development, ramp up or transfer of production lines from another manufacturing facility, with a focus on risk mitigation. Provide quality expertise in the development of production lines to meet cGMP requirements, including approval of procedures, FMEAs, cleanroom practises etc Drive compliance to validation requirements for new product introduction. Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval. Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities). Provide effective and responsive QA support to Operations to meet their area's objectives of quality, cost and output. Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA's). Drive and implement plant wide quality system improvements. Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g. FDA and TUV). Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles). Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques). Approval of change requests for product, process and quality system changes. Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends. Compilation of required Regulatory documentation (e.g. Technical files, Design Dossiers, Product transfer files, Essential requirements). MRB: Review of MRB trends and identification of appropriate corrective actions when required. Support the implementation of Lean Manufacturing across the site. Minimum of Level 8 Honours Bachelor of Science Degree in Engineering/Technology. 3/4 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

Provide QA support for production line development and ensure compliance with cGMP requirements. Drive process improvements and implement quality system enhancements across the manufacturing facility.