포지션 소개
Key Responsibilities:
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Perform final functional testing, product/material release inspections, and record test results accurately
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Review, update, and maintain Quality Assurance (QA) documentation
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Initiate, investigate, and ensure timely closure of nonconformance reports
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Conduct product defect analysis and support root cause investigation and corrective/preventive actions (CAPA)
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Monitor and report quality issues using data from testing, inspections, and process monitoring
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Compile and support reporting activities, including Non-Conformance Board reports and ad hoc management reports
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Collaborate with Quality Engineering and Operations teams to resolve manufacturing and quality issues
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Ensure compliance with QA laboratory procedures, plant-wide processes, and regulatory standards
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Identify opportunities for continuous improvement in product quality and process efficiency
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Escalate concerns related to environment, health, safety (EHS), or quality risks
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For experienced candidates, provide guidance to junior team members and contribute to process improvements
Requirements:
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Minimum Diploma in Science, Engineering, or related field
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3–8 years of experience in a manufacturing environment, preferably in quality or operations
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Experience in medical device or regulated industry is preferred
Skills & Competencies:
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Strong quality mindset with high attention to detail
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Good analytical and problem-solving skills
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Ability to work independently and collaborate effectively within cross-functional teams
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Good written and verbal communication skills in English
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Experience in final functional testing and inspection processes
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Familiarity with manufacturing systems (e.g., MES, SAP)
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Basic understanding of ISO 13485, QMSR, or equivalent quality regulations
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Adaptable, proactive, and able to manage priorities in a fast-paced environment
About Us
As a global medical technology leader for more than 45 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
복지 및 혜택
•교육비 지원
•성과 보너스
•스톡옵션
•홈오피스 지원
필수 스킬
Facilities maintenance
Troubleshooting
Safety procedures
Boston Scientific 소개
Batu Kawan
본사 위치