Senior Quality Assurance

4 weeks ago

Singapur, Singapore Align Technology Full time

About this opportunity

The APAC Regulatory and Quality Assurance Department has a position in APAC for a Senior Quality Assurance (QA) Manager to support the region Quality Management System. This role will lead, establish, maintain, coordinate and support APAC Quality Assurance in meeting Align’s Quality goals via an effective Quality Management System to ensure that business processes across APAC are in full compliance with medical device regulations within the region and Align’s internal requirements. The position also assesses the changes to applicable laws and legislations that could affect the organization in APAC and provides guidance to the APAC function on matters relating to quality. This position is based in Align’s Singapore office and reports directly to the Director, Regulatory Affairs and Quality Assurance, APAC, in the APAC corporate HQs located in Singapore. In this role, you will… Responsible for the implementation and maintenance of the Align Global Quality Framework, Global QMS Policies and Global Standard Operating Procedures which ties to the “One Align” and “Quality First” principles to establish a Global Harmonized Quality standard for Align commercial and manufacturing sites across APAC. Responsible as APAC QMS Harmonization lead to interface with Global/Site QA for the region on matters relating to Global QMS Harmonization. Responsible for APAC Align Sites and their 3rd Party Quality Audit Program; conduct risk assessment to establish the annual APAC Internal Quality Audit Schedule, implement the audit program, create audit plan and lead these internal and external audits to ensure sites’ audit readiness by External Regulatory bodies and Corporate . Drive closure to audit findings including investigation, implementation, and effectiveness checks. Responsible for evaluating region/local sites Change Controls/CAPAs, in collaboration with local RAQA, to determine if issues impact product safety, product labeling, regulatory submissions or requires further actions (e.g., recall) or reporting and coordinate with Global RAQA as needed. Assume the MR role for APAC sites, as applicable. Monitor and assess changes to regulations and policies and proactively identify issues that may have a business impact or of interest to Align. Work collaboratively with APAC process owners to define improvements. Responsible for training of APAC sites on topics relating to QMS, Global QMS Harmonization, Internal Audits, CAPA, Change Management, etc. Supports new business expansion in APAC, ensuring its quality compliance. Assists with all department projects as required. In this role, you’ll need … Over 8 years in Quality Assurance role at a healthcare/medical device company. Fluent in English writing, reading and communication skills to interact with global and regional teams including external regulatory requirements In depth knowledge of Quality System regulations – GMP, GDP, ISO 13485, etc., with its implementation experience and lead auditor skills. In depth CAPA and Change Management experiences. Experience in performing processes mapping, workflows and writing Quality procedures . Excellent written, verbal and interpersonal communication skills with demonstrated ability to effectively communicate with company personnel, consultants, and government officials. A strong commitment to excellence and high standards of integrity, professionalism, loyalty, honesty, respect, open mindedness, open communication, respect, and business ethics Ability to maintain constructive relationships with individuals at all levels within the organizations and influence without direct authority. Ability to work independently, and handle both small and large matters with equal effectiveness and enthusiasm. Execute project/program tasks with general supervision and little guidance. Ability to do research and come up with comprehensive and compliant solutions for quality challenges. Ability to work cross-functionally with multiple projects, solving problems and communicating issues. Must be able to thrive in a fast-paced environment with evolving regulatory landscape, be willing to adapt to change, as well as being capable of driving change. Bachelor Degree in Science or Engineering preferred.

  • Senior Quality Assurance

    2 weeks ago

    Singapur, Singapore Shopee Full time

    Senior Quality Assurance Department Operations LevelExperienced (Individual Contributor)LocationSingapore The Operation teams at Shopee covers the operational end-to-end process, from when the buyer searches for a product listed on the Shopee platform, to the moment the buyer receives the products. The team analyses and monitors operational KPIs across the...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Singapur, Singapore GXS Full time

    Get to know our Team: We design and provide products and services that empower our customers to enjoy greater banking convenience while they extract more value from their money. We are focused on promoting and developing healthy saving and investment practices across generations. Get to know the Role: We are living in exciting times. Technology is...

  • Quality Assurance Manager

    1 month ago

    Singapur, Singapore Survitec Full time

    Vacancy Title : Quality Assurance Manager Vacancy Location:  Senoko, Singapore Engagement Type:  Full-Time (Permanent) Your Company  Survitec are the world’s largest survival technology provider. For over 166 years, we have been protecting lives in the air, on land and at sea, through the design, manufacture, and servicing of...

  • Quality Assurance Specialist

    1 month ago

    Singapur, Singapore AIG Full time

    Your contribution at AIGAs a contributor at AIG you are the one the clients turn to in times of need. You act with speed, composure, compassion and knowledge to solve problems and the work you do every day is the heart of AIG’s business.This role requires the candidate to work in a team of Quality Assurance Specialists, reporting to the Quality & Training...

  • Quality Assurance Specialist

    4 weeks ago

    Singapur, Singapore AIG Full time

    Your contribution at AIGAs a contributor at AIG you are the one the clients turn to in times of need. You act with speed, composure, compassion and knowledge to solve problems and the work you do every day is the heart of AIG’s business.This role requires the candidate to work in a team of Quality Assurance Specialists, reporting to the Quality & Training...

  • Quality Assurance Engineer

    4 weeks ago

    Singapur, Singapore Akribis Systems Full time

    Job Description Track in-process quality-related issues and incidents in master issue list and periodically report on trends, insights, and closure status to BU management. Understand and classify issues into discipline such as quality, operational, design, etc. Host post-mortem discussion during each project closure to review issues and identify...

  • Intern, Compliance Quality Assurance

    3 weeks ago

    Singapur, Singapore ING Full time

    Why ING? The world of banking is changing faster than ever. That’s why we at ING are always broadening our horizons. Our people have a forward-thinking mentality, a strong can-do spirit and enjoy working in an agile environment. ING in Asia Pacific In Asia Pacific, ING offers wholesale banking across 11 markets, namely Australia, China, Hong Kong...

  • Quality Assurance Analyst

    3 weeks ago

    Singapur, Singapore Best Careers and Opportunities Full time

    JOB LOCATION: SINGAPORE JOB TITLE: QUALITY ASSURANCE ANALYST Job Description: Role Purpose: The Quality Specialist will be primarily responsible for performing Quality transaction monitoring across the SMB Programs for internal stakeholders as well as external vendors in APAC. Ideal candidates will need to be proficient in both Customer Service and Sales...

  • [ShopeeFood] Senior/ Associate, Quality Assurance

    1 month ago

    Singapur, Singapore Shopee Full time

    [ShopeeFood] Senior/ Associate, Quality Assurance (Buyer Product) DepartmentProduct ManagementLevelExperienced (Individual Contributor)LocationVietnam - Ho Chi Minh City The Product Management team at Shopee is the key focal point between the business, engineering and design teams. The team is responsible for implementing strategy, road maps and features,...

  • Quality Assurance Analyst

    1 month ago

    Singapur, Singapore PRISM+ Full time

    As part of the overseas department team, you play an essential part in the overseas customer service team to ensure that our customer service agents are equipped with the necessary skills and knowledge to deliver a high quality of service to our clients. Being a high growth electronics company, we are looking for a candidate who will be a strong self-starter...

  • Quality Assurance Manager

    4 weeks ago

    Singapur, Singapore Novo Recruitment Solutions Pte Ltd Full time

    Job Responsibilities:The creation, upkeep, and ongoing enhancement of the organization's Quality Management System (QMS), maritime class approvals, and regulatory obligations .Arrange, plan, and take the initiative to spearhead quality-related projects and advance a culture of quality inside the business.Sustaining and enhancing quality performance to...

  • Quality Assurance Specialist

    4 weeks ago

    Singapur, Singapore Cook Medical Full time

    Overview This role is responsible in the implementation and maintenance of Quality Management System of SADC in Singapore in accordance to ISO 13485 and TradeFIRST requirements. Responsibilities •Assist to develop and maintain Quality Management System(QMS) in compliance with ISO 13485 •Responsible for document control, change control...

  • Customer Quality Assurance Engineer

    4 weeks ago

    Singapur, Singapore Flintex Consulting Pte Ltd Full time

    Job DescriptionObjectives of the position: This role is for the Customer Quality Support for Company’s product distribution where Customer’s feedback & Product Quality requirements / issues are handled. The person will be responsible to handle Customers requirements such as complaints, test data & other technical information as requested. Customer...

  • Product Quality Assurance and IT Governance Deputy Manager

    1 month ago

    Singapur, Singapore PSA International Full time

    As a member of #TeamPSA, you will be part of a diverse and global team at the forefront of creating cargo solutions to enable more agile, resilient and sustainable supply chains. Experience first-hand and drive supply chain transformation from Singapore and through PSA’s global network of ports, logistics and supply chain solutions. Alongside, we can...

  • Data Quality Assurance Engineer

    1 week ago

    Singapur, Singapore TikTok Full time

    About the team The mission of the Data Business Partner (BP) Quality Assurance Team is to build a highly robust(standardized/professional/efficient) data quality system, ensuring the better delivery of data. Our goal is to safeguard the quality of data throughout the entire lifecycle in terms of timeliness, accuracy, and stability, empowering the...

  • Analyst/AVP, Quality Assurance

    1 month ago

    Singapur, Singapore SMBC Group Full time

    Quality Assurance on AML and Corporate Compliance Understand AML, Compliance and regulatory controls in each dept and requirements of applicable regulations and policies Assist to create quality assurance programs in line with Compliance and AML action plans and internal policies Review and update QA programs periodically and upon changes to laws and...

  • Operation Assurance Manager

    2 weeks ago

    Singapur, Singapore Australia and New Zealand Banking Group Limited (ANZ) Full time

    Operation Assurance Manager Operation Assurance Manager Req ID: Department: Insto Ops Risk Assurance Division: Institutional Location: Singapore About the Role At ANZ, we’re shaping a world where people and communities thrive, driven by a common goal: to improve the financial wellbeing and sustainability of our customers. Our Institutional bank helps...

  • Customer Quality Assurance Engineer

    4 weeks ago

    Singapur, Singapore Flintex Consulting Pte Ltd Full time

    Objectives of the position: This role is for the Customer Quality Support for Company’s product distribution where Customer’s feedback & Product Quality requirements / issues are handled. The person will be responsible to handle Customers requirements such as complaints, test data & other technical information as requested. Customer complaints handling...

  • Customer Operations Quality Assurance

    3 weeks ago

    Singapur, Singapore Shopee Full time

    Customer Operations Quality Assurance - Operations (Solo, Contract-Based) Department Operations LevelEntry LevelLocationIndonesia - Solo The Operation teams at Shopee covers the operational end-to-end process, from when the buyer searches for a product listed on the Shopee platform, to the moment the buyer receives the products. The team analyses and...

  • Quality Assurance Manager

    1 month ago

    Singapur, Singapore Gammon Full time

    Responsibilities: Formulate and implement QA/QC management system at project site Educate and enforce a proper understanding of the QA role and function for all on site Promote a strong quality culture across the organization Preempt problem/quality risk and highlight areas for improvement Conduct training for site personnel and subcontractor’s...