Lowongan Kerja Depok Posisi Quality Control Manager di jenco mulia teknologi

Info Loker

Perusahaan	jenco mulia teknologi
Posisi	Quality Control Manager
Tempat	Depok
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Penjaminan & Kontrol Mutu (Manufaktur, Transportasi & Logistik)

Responsibilities :

• Adheres to Resolution Medical’s Core Beliefs and all safety and quality requirements.
• Non-Conforming Material Reports (NCMR) including root cause investigation, risk assessment, historical record review, disposition strategy, correction activities.
• Complaint Reviews/Manufacturing Analysis including event assessment, root cause investigation, risk assessment, historical record review, impact/action escalation.
• Corrective Action Preventive (CAPA); including root cause investigation, scoping/bracketing, resolution planning, implementation, and verification of effectiveness.
• Regulatory requests including certification of compliance and product inquiries.
• Manufacturing/Production Line Support – partnering with operations team members to achieve value stream goals and objectives.
• Change Control – lead documentation change orders per quality system requirements.
• Validation/Qualification – Lead/review Installation Qualification, Process Qualification, Operational Qualification, Product Performance Qualification (PPQ), Master Validation Plan/Report, and Test/Inspection Method Validation.
• Deviations – including risk assessment, closure criteria.
• Risk Management – use and interpret Hazard Analysis, use/update/create Failure Modes and Effects Analysis.
• Foster/sustain “Voice of Quality” and “Quality 1st mindset”.
• Support backroom during audits.
• Line Reviews – supports timely completion of manufacturing front line personnel reviews.
• Provide leadership and support to 2-3 direct reports for their professional and personal development
• Provide work direction and support to 2-3 direct reports for their professional and personal development
• Recommend and make changes to QMS procedures, SOPs, Work Instructions and other related documents as necessary
• Performs other functions as required

Requirements:

Education, Experience, and Required Skills:

• Bachelor’s in Industrial Engineering, Electromedic 5+ years of experience in Quality Operations in a medical device company.
• 5+ years Quality experience in medical device manufacturing or related industry.
• Thorough knowledge of and experience with FDA regulations, ISO 13485, ISO 14971, CAPA, Complaint/MDR.
• Have a leadership.

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Deskripsi Perusahaan

Info Perusahaan

• Industri: Manufaktur/Produksi
• Lokasi: kalimulya