Associate Quality Manager - M2 at Boston Scientific Corporation Malaysia

The Municipal District of Newcastle West, Munster, Ireland -

Full Time

Start Date

Immediate

Expiry Date

16 Mar, 26

Salary

0.0

Posted On

16 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Process Improvement, Regulatory Compliance, Statistical Techniques, Lean Manufacturing, Problem Solving, Team Leadership, Quality Audits, Risk Reduction, Yield Improvement, Customer Complaint Reduction, Error Proofing, Cost Reduction, Process Automation, FMEA, DOE Studies

Industry

Medical Equipment Manufacturing

Description

Supervision of Quality Technicians and Quality Engineers. 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: Approval of analysis reports and analysis of complaint trends. Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval. 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. Perform internal quality audits. Support the implementation of Lean Manufacturing across the site. Transfer and implement product and processes from development or from another manufacturing facility. Monitoring of key quality metrics in areas of responsibility to identify improvement opportunities. Requires a minimum level 8 relevant Engineering / Science degree Excellent interpersonal and communication skills with good leadership abilities. Ability to work as part of a team and meet targets/goals efficiently. Excellent analytical and problem-solving skills. Minimum of 4+ years' experience within the medical device or pharmaceutical manufacturing industry - people management experience an advantage. Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.

Responsibilities

Supervise Quality Technicians and Engineers while driving process improvements across product lines. Ensure compliance with regulatory standards and provide QA support to meet operational objectives.