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Senior Quality Engineer

Senior Quality Engineer

CochlearKuala Lumpur, Kuala Lumpur, Malaysia
1 hari lalu
Penerangan pekerjaan

Cochlear Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Cochlear's mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies.

Opportunity

We are seeking an individual to join our fast‑paced team as Senior Quality Engineer to ensure regulatory compliance across the Quality Management System (QMS) and products. The role provides ongoing support to Production and Engineering teams, identifies and implements improvements, and provides Quality System & Regulatory mentoring.

Key Responsibilities

  • Ensure regulatory compliance across the QMS and products, partnering with stakeholders to meet FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP, and related standards.
  • Assist in identifying, evaluating, containing, investigating and applying corrective actions for Class 3 Active Implantable Medical Devices across Manufacturing and Logistics.
  • Support the Non‑Conformance Report (NCR) process and concession implementation.
  • Support first‑time quality, fast‑response and morning‑market meetings.
  • Conduct internal audits and manage external audits.
  • Review QMS documents for proposed changes or product‑related changes.
  • Identify, initiate and implement improvements to QMS processes.
  • Produce key performance metrics, data analysis on Non‑conformance reports and ensure timely delivery of periodic reports.
  • Partner with Process Engineering and Validation teams to design Manufacturing Quality Plans and assess opportunities to tighten or reduce sampling.
  • Ensure appropriate training is delivered for process changes and improvements.

Position Specific Skills and Challenges

  • Comprehensive understanding of ISO 9001, ISO 13485, FDA QSR (21 CFR Part 820), MDSAP, EU MDR and ability to apply these standards effectively.
  • Strong capability in analyzing processes and issues, using risk‑based methodologies, FMEA, root cause analysis and statistical process control.
  • Skill in developing, reviewing and maintaining high‑quality procedural and technical documentation with consistency and standardisation.
  • Working knowledge of manufacturing quality practices : design transfer, MQP, IQC / FOA, risk management and change management.
  • Preferably certified internal auditor (ISO 13485 or ISO 9001) with experienced internal and external audits.
  • Proficient in writing precise procedural and technical documents and maintaining accuracy.
  • Independent task management with collaboration across teams, stakeholders, and strong interpersonal skills.

    • Why is this role right for you?

  • Minimum Bachelor’s degree in Electrical / Mechanical Engineering or equivalent.
  • At least 6 years of experience in quality or manufacturing operations in regulated medical device industry, with a minimum of 4 years as a Senior Quality Engineer.
  • Experience with quality management tools, data analysis, metrics, reporting and statistical methods.
  • Hands‑on experience managing NCRs, CAPA, concessions and product acceptance processes.
  • Highly developed audit capability and experience with internal and external audits.
  • Direct experience in improving QMS processes, collaborating with NPI and Validation teams on MQP.
  • High analytical, problem‑solving and reporting skills plus proficiency in procedural documentation.
  • Independent work style with strong stakeholder management and excellent organizational skills.
  • Attention to detail, passion for consistency, standards and complete documentation.
  • Proficient in data analysis using Excel, Power BI or similar tools, and experience with MES, ERP, QMS platforms.

    • Desired Skills and Experience

    In‑depth knowledge of QMS, continuous improvement methodologies, change management, manufacturing quality practices, and effective management of Non‑Conformance Reports and Concessions.

    Seniority Level

    Mid‑Senior level

    Employment Type

    Full‑time

    Job Function

    Engineering, Manufacturing, and Quality Assurance

    Industries

    Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Semiconductor Manufacturing

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    Buat amaran kerja untuk carian ini

    Quality Engineer • Kuala Lumpur, Kuala Lumpur, Malaysia