Engineer, Quality Management System

7 months ago

Singapur, Singapore ResMed Full time
*This will be a 1-year fixed term contract role

Let’s talk about the team:

The primary role of the Quality Assurance, Quality Systems function is to ensure that management systems are established to enable business compliance, multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer’s quality requirements.

The Quality Assurance - Quality Systems function supports:

All aspects of the audit program to ensure regulation compliance, quality best practice, process improvements and development of supplier quality systems. Providing broad business technical support around QA systems and processes to the organization. Supports and implements significant quality projects across the business and also creates and improves quality and business processes. The management, maintenance, and optimisation of the structure and integrity of the Global Quality Management Systems (QMS) to ensure ResMed’s products and our design and manufacturing operations comply with the regulatory requirements applicable to medical devices for the markets in which they are distributed.


Let’s talk about the role:

Support preparation of and implement a comprehensive internal and supplier audit program that meets the requirements of the business and applicable external regulatory bodies. Project manage the activities resulting from observations and non-conformances raised during internal audits and as part of CAPA investigations. Liaise with stakeholders and drive these findings to effective and timely closure. As required, support and represent ResMed in external audit situations through audit preparation, facilitation and acting as a direct auditee when required. Support the management, maintenance, and optimisation of the structure and integrity of the Global Quality Management Systems (QMS) to ensure compliance and alignment with applicable regulatory standards and business requirements. Support in the consultation and collaboration with Global Business Process owners to interpret, construct and apply robust processes into the Global QMS. Support the implementation of a Global QMS. Review, analyse and implement opportunities for continual improvement of the Global QMS to meet business needs. Provide reports and metrics to management on the status of the Audit and Global QMS programs and provide an assessment of the possible resulting business impact. Build strong networks and work with teams in other ResMed locations to ensure that Quality Assurance systems/processes are in alignment Globally. Undertake other Quality Assurance Systems support and other ad hoc activities as required, including Audits and QMS support.


Let’s talk about you:

Required:

Bachelor Degree in Science or Engineering. Experience of ISO13485 and 21 CFR Part 820 requirements. Minimum 2 years applied professional quality assurance experience ideally including the medical industry. Formal Training and experience in Quality System audits. Moderate audit experience Strong listening, verbal and written communication skills. The ability to identify linkages and dependencies between processes.

Preferred:

Experience in the maintenance of Management Systems including ongoing improvement of systems and processes. Ability to think clearly and critically, assess information and evidence to make informed, timely decisions. Ability to successfully influence others to achieve outcomes. Agility to adapt and respond quickly while being resilient to overcome obstacles. Experience in process improvement and value stream mapping. Acting as lead or experienced supporting auditor for internal and supplier audits, covering a range of relevant processes and supplier types.

#LI-CF

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now

  • Quality System Engineer

    7 months ago

    Singapur, Singapore EDMI Limited Full time

    Job Title: Quality System Engineer (partially supporting Subcon)Job Level: EngineerObjectivesSupport the QMS manager in the maintenance & continuous improvement of all the Management System (ISO9001, ISO14001, ISO45001, ISO27001, ISO17025, MID-D, LNE, QC80000, IECEx80079) of EDMI group including procedures and processes documentations. Co-ordinate and ensure...

  • Quality Management Systems

    7 months ago

    Singapur, Singapore 825 Glaxo Wellcome Manufacturing Pte Ltd Full time

    To lead, support and maintain effective and compliant quality systems relating to: Change Control System Quality Management System (QMS) Quality Alerts and Quality Bulletins Deviation Management System Corrective Action and Preventive Action (CAPA) System Product Quality Review (PQR) General For each assigned Quality System(s) : Lead...

  • Senior / Engineer - Quality System

    4 months ago

    Singapur, Singapore UTAC group Full time

    Senior / Engineer - Quality System 5 Serangoon North Ave 5, Singapore 554916 Req #448 Saturday, September 7, 2024 Please join us! Responsibilities: Lead, coordinate and facilitate customer and 3rd party audits (ISO9001, IATF16949, ISO26262). Ensure the smooth conduct of audits through thorough co-ordination and pre-arrangements Plan, schedule...

  • Senior Engineer Quality Management System

    6 months ago

    Singapur, Singapore SSMC Full time

    SSMC (Systems on Silicon Manufacturing Company Pte. Ltd.), is a Joint Venture between NXP and TSMC. We offer flexible and cost effective semiconductor fabrication solutions by maintaining fully equipped SMIF cleanroom environment, 100% equipment automation and proven wafer-manufacturing processes. At SSMC , every career journey is unique and rewarding....

  • Quality Engineer

    7 months ago

    Singapur, Singapore Talent Trader Group Full time

    Responsibilities: Develop and implement quality control processes and procedures to ensure product quality and reliability. Conduct inspections and tests on incoming materials, in-process components, and finished products to ensure compliance with quality standards. Monitor and analyze quality data to identify trends and areas for improvement. Collaborate...

  • Internship - Quality Management System

    5 months ago

    Singapur, Singapore Infineon Technologies Full time

    The student, as part of the BE QM QMS team and under the guidance of an assigned mentor, will undertake projects or tasks to work on improvements or enhancement to quality improvement initiatives, data analytics, reporting, systems, tools and methods.In your new role you will: Setup tools ( excel macro, tableau) to enable fast data extraction, analysis...

  • Quality Engineer

    6 months ago

    Singapur, Singapore ST Engineering Full time

    Title: Quality Engineer Job ID: Location: Aero - Airport Road, SG Description: Primary Responsibilities: General You will Report to the Head of AMDC to lead AMDC’s (Advanced Manufacturing Design Centre) quality assurance aspect. Support ST Engineering Aerospace quality management system and quality plan Production Quality for...

  • Quality Engineer

    6 months ago

    Singapur, Singapore ST Engineering Full time

    Title: Quality Engineer Job ID: Location: Aero - 8 Changi North Way, SG Description: Key Job Accountabilities: Liaison with customer reps on documentation procedures including certification and maintenance release. Ensure all aircraft have valid documents such as Certificate of Registration, Certificate Of Airworthiness, Radio License,...

  • Quality Engineer

    7 months ago

    Singapur, Singapore Rolls-Royce Full time

    Description A new opportunity has arisen for a skilled Quality Engineer like you, to oversee and bring expertise to our team. Rolls-Royce Power Systems is headquartered in Friedrichshafen in southern Germany and employs around 9,000 people. The product portfolio includes mtu-brand high-speed engines and propulsion systems for ships, power generation,...

  • Quality Engineer

    6 months ago

    Singapur, Singapore Flintex Consulting Pte Ltd Full time

    Job DescriptionJob Summary Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative.Role and ResponsibilitiesQuality Systems1. Supports overall maintenance of quality systems2. Monitor and reports on the quality performance for Asia...

  • Principal Quality Engineer.

    7 months ago

    Singapur, Singapore Medtronic Full time

    Careers That Change Lives Engineers are indispensable to achieving our Mission. That’s why we empower you to bring the best of your experience to bear on our market-leading portfolio of innovations. Apply your existing skills and develop new ones, with the training, mentorship, and the guidance you need to continue to develop your expertise. With...

  • Quality Manager

    1 month ago

    Singapur, Singapore Careers@Gov Full time

    What the role is This position is under the Enterprise Student Management System Department (ESMS). What you will be working on Reporting to the ESMS Project Director, lead the planning and execution of end-to-end testing to ensure all system modules are thoroughly validated and their dependencies function seamlessly within the Enterprise Student...

  • Product Quality Engineer

    2 months ago

    Singapur, Singapore 3M Full time

    3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: Assumes responsibility for initiating and performing defined...

  • Quality Engineering Intern

    2 months ago

    Singapur, Singapore Skyworks Full time

    If you are looking for a challenging and exciting career in the world of technology, then look no further. Skyworks is an innovator of high performance analog semiconductors whose solutions are powering the wireless networking revolution. At Skyworks, you will find a fast-paced environment with a strong focus on global collaboration, minimal layers of...

  • Quality Engineer

    6 months ago

    Singapur, Singapore Flintex Consulting Pte Ltd Full time

    Job Summary Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative.Role and ResponsibilitiesQuality Systems1. Supports overall maintenance of quality systems2. Monitor and reports on the quality performance for Asia Operations such as...

  • System Engineer

    4 months ago

    Singapur, Singapore Encora Inc. Full time

    System Engineer A System Engineer focuses on designing, implementing, and managing complex systems and infrastructure Experience: 6 years Job Mode: Full-time  Work Mode: On-site  Responsibilities Tech refresh old Solaris/AIX machine to new virtual machine AIX/Solaris OS patching and version upgrade Automate system admin tasks Server...

  • Quality Engineering Intern

    2 months ago

    Singapur, Singapore Skyworks Full time

     If you are looking for a challenging and exciting career in the world of technology, then look no further. Skyworks is an innovator of high performance analog semiconductors whose solutions are powering the wireless networking revolution. At Skyworks, you will find a fast-paced environment with a strong focus on global collaboration, minimal layers of...

  • Supplier Quality Management Engineer

    7 months ago

    Singapur, Singapore SSMC Full time

    SSMC  (Systems on Silicon Manufacturing Company Pte. Ltd.), is a Joint Venture between NXP and TSMC. We offer flexible and cost effective semiconductor fabrication solutions by maintaining fully equipped SMIF cleanroom environment, 100% equipment automation and proven wafer-manufacturing processes. At  SSMC , every career journey is unique and...

  • System Engineer

    6 months ago

    Singapur, Singapore Siemens Pte Ltd Full time

    To create a better future, you need to think outside the box. That’s why we at Siemens need innovators who aren’t afraid to push boundaries to join our diverse team of tech gurus. Got what it takes? Then help us create lasting, positive impact! Whatwill you do? SmartBuilding Solutions (SBS) is a Regional Solution and Service business unit, partof...

  • Quality Assurance Engineer

    6 months ago

    Singapur, Singapore Amazon Asia-Pacific Holdings Private Limited - D43 Full time

    Do you want to own cutting-edge technology, solve new problems that didn’t exist before, and have the ability to see the impact of your successes?Amazon is shaping the future of digital video entertainment. We seek engineers who can help us shape and develop new video streaming capabilities for Amazon. This is an exciting opportunity for a rock-star...