Lowongan Kerja Senior Quality Engineer Iso13485 Excelitas Technologies Batam

Job Title : Senior Quality Engineer ISO13485
Date : 31 Maret 2021
Company : Excelitas Technologies
City : Batam

Rekrutmen Excelitas Technologies Batam. Jika kalian sedang mencari lowongan kerja bulan Mei 2021, maka Anda berada di portal yang tepat. Ada banyak kategori lowongan yang bisa Anda lamar mulai dari lowongan kerja SMA SMK terbaru, hingga lowongan kerja S1. Saudara juga bisa mendaftar lowongan kerja online atau offline tergantung kualifikasi yang ditetapkan pada info lowongan yang kami share di loker.informasicpnsbumn.com. Informasi rekrutmen yang valid, bersumber dari web resmi atau media sosial perusahaan yang berkaitan, dan yang pasti tidak ada pungutan biaya apa pun.

Loker Excelitas Technologies Batam Mei 2021

Silakan simak info selengkapnya berikut


is a global technology leader focused on delivering innovative, high-performance, market-driven photonic solutions to meet the illumination, optronics, detection and optical technology needs of global customers. Serving a vast array of applications across biomedical, scientific, safety, security, consumer products, semiconductor, industrial manufacturing, defense and aerospace sectors, we stand committed to enabling our customers' success in their end-markets.

We are behind the technology that powers your cell phone, preserves natural resources, protects troops and cures disease.

Our open-minded and passionate approach to everything we do gives meaning to our technology solutions – we want our forward-thinking ideas and concepts to come into fruition, and to contribute to something greater.

Our Excelitas facility in Batam, Indonesia specializes in the production of lighting and detection product technologies including our Specialty Lamps for industrial and photonics applications, IPL Lamps and Trigger Coils, as well as Infra-Red Detectors (IRD), Sensor Modules and Pyro-electric Ceramic Wafers. Operating since September 1994, this site is also responsible for manufacturing of our Thermopile Sensors (TPS), Thermopile modules (TPM), CCD Sensors and Printed Circuit Board Assemblies.

We are looking for:


Position Overview

This position is responsible to establish, implement and maintain site ISO 13485:2016 Quality Management System to meet requirements of the standard, including hosting and managing both registrar audit and customer audits. This role also support manufacturing process improvements, make significant contribution to the strategic goal of quality improvement pertaining to ISO 13485: 2016 Quality Management System, aiming at meeting customer needs and expectation in quality, cost, and on-time delivery. This role will report to the site Senior QA Manager.

Duties and Responsibilities

  • Primary contact for the organization regarding all matter related to management of ISO 13485 quality assurance
  • Ensure the risk based Quality Assurance Plan, Objectives, Targets and Action Plans are measured and defined managed at each lever of the organization
  • Manage and maintain quality management system to comply the latest versions of ISO13485
  • Develop procedures and implement new standard
  • Develop risk based audit schedule and deliver compliance audits
  • Work with Senior QA Manager to develop a risk based field quality assurance plan and manage in line with the contract and customer’s requirement
  • Be the point of contact with the customer for audit reports, nonconformance, etc (related to ISO 13485)
  • Produce contract and mandatory quality performance monitoring reports as an input to the management review process
  • Provide specialist support to business managers to facilitate root cause analysis workshop for defect/problem trends identified in management review / performance monitoring
  • Develop (with relevant owners and stakeholders) appropriate guidance and procedural documentation (procedures, policies, and process documents) to ensure all activities are carried to ISO 13485 accreditation.
  • Provide specialist support during customer and certification body audits
  • Liaise with the supplier quality engineers to ensure assessment of existing or potential suppliers are effective and timely
  • Ensure that standards for quality are designed into new business processes, products, and services (as part of their transition into delivery) through effective assurance arrangements.
  • Facilitate the customer feedback, complaints, and performance scorecard review process and ensure that findings are analyzes, acted upon and reported as agreed with the customers.
  • Provide status updates to corporate regulatory compliance where applicable and necessary


  • Bachelor of Science/Engineering degree required in Electrical, Industrial, Mechanical, or Physics
  • At least 5 years of experience in a Quality Management role, specifically to Medical Devices Industries that complied with ISO 13485 Quality Management System
  • Experience in the design and implementation of management systems certified to ISO 13485
  • Practical experience in the implementation of field/product quality control processes in the medical devices industries
  • Hands-on certified auditor in ISO13485 QMS will be highly desirable
  • Practical problem solving skills and excellent presentation skills
  • Excellent English verbal and written communication skills, having professional demeanor and customer oriented mindset.
  • Resilient in the face of change and able to support and adopt changes

Why Work for Us

is a great place to work.

We know that the work we do at Excelitas has a greater purpose. As technology innovators of the future, we push the boundaries of what is possible through international collaboration, trusted experience and a sense of purpose.

With over 6,700 employees making up the Excelitas team, our pioneering solutions have benefitted industries such as Automotive, Consumer Products, Defense and Aerospace, Industrial Manufacturing, Medical, Safety and Security, and Sciences.

Our open-minded and passionate approach to everything we do gives meaning to our technology solutions – we want our forward-thinking ideas and concepts to come into fruition, and to contribute to something greater.

As an employer, we Engage with smart minds in order to maintain a creative and empowering work environment. We Enable our employees by providing the tools and resources that allow them to reach their full potential. Finally, we Excel in what we do and we reward hard work.

At Excelitas, you are how we Excel.


Requirements ISO13485 QMS


Thank you for your interest in Excelitas. We respect your privacy. We need your consent to save your contact information and CV and for you to confirm that we can contact you in the future. Please know that Excelitas will never share or sell your contact data.

Pengiriman Lamaran :

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Catatan :

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