Senior Quality System Engineer
Penang Island, Malaysia
Job Description
Senior Quality System Engineer
Boston Scientific\'s hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.
Remote Eligible: Onsite
Onsite Location(s): Pulau, Penang, MY
Location: [[city]], [[stateProvince]], [[country]]
Additional Locations: Malaysia-Penang
Hiring Manager: [[hiringManagerName]]
Recruiter: Jason Tan
Purpose Statement Establish and support a work environment of continuous improvement that supports BSC\xe2\x80\x99s Quality Policy, Quality System, and the appropriate regulations for the area. Key Responsibilities
- Responsible for the implementation, co-ordination and continuous review of the CAPA, Internal and Corporate Compliance programs in Boston Scientific Penang.
- Has expertise in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO and MDD).
- Plan, coordinate and conduct scheduled audits to assess compliance with FDA, ISO, MDD, other applicable standard requirements and internal requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings.
- Provide guidance for Auditors as necessary.
- Manage and/or support audit frontroom and backroom activities during external audits
- Responsible for conducting, and confirming follow-up actions on Corporate/Divisional/Site Compliance Audits
- Attend global conference calls and meetings related to the internal audit process and etc.
- Drives changes in procedures and standards to facilitate work efficiency and to maintain quality.
- Facilitation of CAPA management in other area of the organization.
- Conduct Quality System Training to BSC Penang employees.
- To lead system improvement teams using a variety of different methodologies and selecting appropriate techniques for problem solving and process improvements.
Job Segment: Senior Quality Engineer, Internal Audit, Quality Engineer, Compliance, Systems Engineer, Engineering, Finance, Legal
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Job Detail
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Job IdJD878695
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationPenang Island, Malaysia
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EducationNot mentioned