Current jobs related to Manager, Quality Operations - Tuas - Alcon

  • Quality Manager

    2 days ago

    Tuas, Singapore TechWare Group Full time

    **#QualityManager #QualityAssurance #QualityControl #QualityManagementSystem #ISO #API #NDE #InternalAudits #CNCTurning #CNCMilling #OilandGas** **Salary Package**: SGD4, 000 - SGD6, 300 **Job Location**: Singapore, West, Tuas **Job Types**:Full time, Onsite, 5 days **Responsibilities**: - Responsible for the API, ISO and Safety certification program...

  • Quality Operations Specialist

    2 weeks ago

    Tuas, Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time

    Quality Operations Associate must assist site management to oversee the quality system execution on the manufacturing and production areas at all times. The personnel are required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product and are responsible to ensure highest quality and compliance of...

  • Sr / Quality Manager

    10 hours ago

    Tuas, Singapore PALL FILTRATION PTE LTD Full time

    10 years exp **Roles & Responsibilities** Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests...

  • Quality Engineer

    2 days ago

    Tuas, Singapore Alcon Full time

    Quality Engineer This position is responsible for ensuring the design transfer and manufacturing operation activities of medical devices produced to meet the requirements of Alcon standards, 21 CFR Part 820, Part 11, ISO 13485, the Medical Device Regulation (MDR), and other applicable regulations and standards. This position supports both Program Management...

  • Vendor Quality Management and Sourcing Lead

    4 days ago

    Tuas, Singapore HMT Tank Full time

    **Vendor Quality Management and Sourcing Lead - Asia**: **About HMT** HMT was founded in 1978 with the objective of providing better technology to the aboveground storage tank market. HMT's founders created products which not only solved the emissions problems of the day but also eliminated the operational issues created by the existing floating roof and...

  • Quality Manager

    7 days ago

    Tuas, Singapore TechWare Group Full time

    **#QualityManager #QualityAssurance #QualityControl #QualityManagementSystem #ISO #NDE #AmericanPetroluemInstitute #InternalAudits #CNCTurning #CNCMilling #OilandGas** **Salary Package**: SGD4, 000 - SGD6, 300 **Job Location**: Singapore, West, Tuas **Job Types**:Full time, Onsite, 5 days **Responsibilities**: - Responsible for the API, ISO and Safety...

  • Engineer, Quality Systems

    2 weeks ago

    Tuas, Singapore Kuok (Singapore) Limited Full time

    **Engineer, Quality Systems at PaxOcean Singapore Pte Ltd (Based in Tuas)**: This role ensures compliance with ISO 9001:2015 by maintaining and improving the Quality Management System (QMS). Responsibilities include managing QMS document revisions, audits, supporting continual improvement initiatives, conducting quality training, analysing quality data, and...

  • Sr / Quality Engineer

    10 hours ago

    Tuas, Singapore PALL FILTRATION PTE LTD Full time

    6 years exp **Roles & Responsibilities** Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests lie...

  • Officer, Quality Distribution

    5 days ago

    Tuas, Singapore Alcon Full time

    Major Accountabilities Duties are listed in order of greatest importance. Other responsibilities may be assigned. Essential Functions - Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements. - Support, perform and/or lead internal audits, supplier audits and external/regulatory audits, including updating and maintenance...

  • Technician, Quality Operations

    5 days ago

    Tuas, Singapore Alcon Full time

    COMPANY OVERVIEW: At Alcon, we are passionate about enhancing sight and helping people see brilliantly. With over 25,000 associates worldwide, we innovate fearlessly, champion progress, and act swiftly to improve global eye health. We foster an inclusive culture that values your contributions and supports your career growth. Join us and make a meaningful...

Manager, Quality Operations

2 weeks ago

Tuas, Singapore Alcon Full time

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

As a Quality Operations Manager, you will oversees and ensure that the manufacturing of medical devices produced meets the requirements of Alcon standards, 21 CFR Part 820, Part 11, ISO 13485, the Medical Device Regulation (MDR) and other applicable regulations and standards. This applies in all operational aspects, including but not limited to, site validation, Computer System Validation (CSV), risk management activities, non-conformance investigations, change requests, document review & approvals etc.

In this role, a typical day will include:

- Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements.
- Contributes to the site Quality Management System by ensuring its effective implementation in the organization through self-inspections, performance metrics and management reviews.
- Establish and manage the processes for Computer System Validation (CSV) & Non-Conformances, including training effectiveness and oversight on execution.
- Provide e-compliance oversight to site CSV activities, and provide guidance and coaching to CSV SME.
- Dive deep and maintain the technical understanding needed to actively contribute to engineering and product decision-making for both LS1 & DSM Flex platforms.
- Provide oversight on all site validation activities, manufacturing projects, including laboratory equipment and method transfers, infrastructure, utilities and supporting functions.
- Provide oversight, guidance & make informed decisions for expansion projects, technical transfers/ new design or design transfers etc within both platforms.
- Participate in management of nonconformance & CAPA program to ensure timely follow-up, completion, documentation & disposition of products.
Review and approve manufacturing operational activities, such as nonconformance, CAPA, escalations, change requests, SOPs, Forms, MROM, IMR etc.
- Provide quality oversight to activities related to calibration, preventive maintenance, spare part assessment, PLC changes, and associated deviations.
- Oversee continuous monitoring activities and review key performance indicators, suggest improvements and escalate to supervisor/management as necessary.
- Support in preparing, presenting and managing cost centre budget and forecast accuracy, including personnel cost.
Responsible for quality evolution project pipeline, cost savings and continuous improvement within the quality function.
- Support internal and external audits, responsible for audit finding closure, as required. Work with cross-functional teams to resolve operational quality issues.
- Perform internal quality audits (IQA) as lead auditor to ensure operational compliance.
- Backup to the Quality Operations Senior Manager, as required.
Performs any other duties as assigned by Supervisor according to business needs.

WHAT YOU’LL BRING TO ALCON:

- Bachelor/ Degree in Science, Life Science, Engineering or other appropriate education and experience in pharmaceutical and medical device industry.
Min 5 years of experience in Quality Assurance or Quality Control in a Pharmaceutical and Medical Device with minimum leadership experience of 3 years with at least 5 direct reports
- Have good knowledge of cGMPs, ISO13485, 21 CFR Part 11 and/ or ISO9001 requirements.
- Extensive experience in validation activities including CSV
- Good Knowledge of Change Control, Document Control, Training Systems and/ or Non conformance systems will be of added advantage.

HOW YOU CAN THRIVE AT ALCON:

- Good team player
- Enjoy working with various cross functional team across manufacturing site

Alcon Careers

ATTENTION: Current Alcon Employee/Contingent Worker

Find Jobs for Employees

Find Jobs for Contingent Worker