Sr, Quality Manager at Boston Scientific Corporation Malaysia

, , Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

09 Feb, 26

Salary

0.0

Posted On

11 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Process Control, Process Validation, Statistical Techniques, Six Sigma, Lean, Leadership, People Development, Manufacturing Operations, Risk Analysis, Technical Support, Non-Conforming Product, CAPA Process, Inspection, Calibration, Microbiology

Industry

Medical Equipment Manufacturing

Description

Plan, coordinate and execute projects oriented toward in-process defect prevention Design and implement process control and/or improvement strategies. Provide support to new products/process transfer projects; review risk analysis for the different processes and participate as a core team member in the new products transfer process, representing Quality Assurance areas Provide technical support to the Manufacturing Operations area and to other departments Serve as Subject Expert Matter (SME) of the following: Production and Process Controls, Process Validation, Identification and traceability, Inspection, measuring and test equipment, Non-conforming product/process up to CAPA process, Acceptance activities, Manufacturing related post-market activities. Develop, coordinate and implement, in collaboration with Corporate/Divisional teams, projects related to the Manufacturing Operations Quality area. Facilitate and support the Quality function through Quality Engineers and Quality technicians. Develop and maintain a healthy pipeline of succession. Review and/or approval of documents, investigations, change notices or another regulatory figure within the company´s quality system, as an alternate representative of Quality Management. May provide support to the Quality Director in his/her responsibilities. Authorized to sign as the Quality Director designee or representative in his/her absence or as required. May act as the owner or Quality Director designee in PIR (Product Inquiry Report) process activities, inclusive of execution and appropriate process communication to Corporate stakeholders. May provide guidance to process validation areas, software validation, complaint handling, MTAC, Calibration, Microbiology, Supplier Engineering, Quality process development, and/or design assurance. Bachelors or above Degree in Engineering fields such as Chemical, Electronic, Materials, Electromechanical, Industrial Engineering, Biological Science or related fields. English Level desired: C1:(90-94%). Desired knowledge: Formal training on statistical and quality techniques, desirable ASQ Certified, Knowledge of Six Sigma, Lean or similar tools. Desirable MBA in applicable fields. Strong leadership skills and proven track record of people development. At least 10 years of experience in a similar position. Or an equivalent combination of education and experience

Responsibilities

The Sr. Quality Manager will plan, coordinate, and execute projects focused on in-process defect prevention and implement process control strategies. They will provide technical support to manufacturing operations and participate in new product transfer processes as a core team member.