Current jobs related to Senior Quality Assurance - Downtown Core - AlignTech
-
Quality Manager
1 day ago
Downtown Core, Singapore Chison SG Pte Ltd Full time**Responsibilities**: - Lead and Responsible for manufacturing quality assurance including incoming quality, in-process quality, semi-finished product quality, and outgoing product quality - Manage product inspection, customer specifications and requirements - Drive incoming quality assurance process improvement in efficiency and effectiveness - Engage...
-
Engineering Quality Lead Engineer
7 days ago
Downtown Core, Singapore Anotech Singapore Full timeALTEN Group is a world leader in Engineering and Technology consulting services providing outsourced Engineering, R&D, and IT Services for different industries such as Transportation, Defence, Energy and Security with 55,000 engineers in nearly 35 countries. ANOTECH is the subsidiary of the Group delivering ALTEN's Engineering Services in Singapore. As an...
-
Software Quality Assurance Intern
1 week ago
Downtown Core, Singapore Rakuten Asia Pte Ltd Full timeAs a Software QA Intern of our Technology Management Section, the incumbent will be working with the team to develop and execute test plans, test cases, and test automation scripts to ensure the quality of the software products. **Responsibilities**: - Develop and execute test plans, test cases, and test automation scripts. - Perform manual, regression,...
-
Consultant
7 days ago
Downtown Core, Singapore Greenwich Associates Full timeThis incumbent is primarily responsible for data collection. With a slice of work being carried out in person, we seek a well-presented and eloquent individual to be place in front of senior executives. This freelance position have guaranteed work throughout most months of the year. **Job Scope** - Establish appointments from a portfolio of key decision...
-
Downtown Core, Singapore Agency for Integrated Care Pte Ltd Full timeThe role of Community Partnerships plays a pivotal role in fostering strong collaborations between AIC and strategic partners such as the Health Promotion Board (HPB), People’s Association (PA), SportSG, and other government agencies, statutory boards, and community organisations. The role also involves engaging and onboarding new agencies to refine Active...
-
Senior / Manager, Quality Improvement
2 weeks ago
Downtown Core, Singapore Agency for Integrated Care Pte Ltd Full timeStakeholder Engagement with Internal Divisions and Community Care Organisations - Build and maintain strong working relationships with internal Divisions and external community care partners. - Engage both stakeholders to encourage participation in Quality Improvement (QI) initiatives. - Conduct ground sensing through meetings, observations and focus groups...
-
Business Manager
3 days ago
Downtown Core, Singapore HL Assurance Pte Ltd Full time $80,000 - $120,000 per yearMain Responsibilities:Reporting to the Head of Commercial Lines and Distribution, you will be responsible toDrive new business revenue growth and maintain excellent retention of existing business production in a multi-channel distribution portfolio, primarily focused on AgencyAcquire new business partners by analyzing market conditions and examining...
-
Audit - SG (Associate to Senior Associate)
5 days ago
Downtown Core, Singapore Deloitte & Touche LLP Full time $60,000 - $120,000 per yearCompany description: "Deloitte" is the brand under which tens of thousands of dedicated professionals in independent firms throughout the world collaborate to provide audit & assurance, tax & legal, strategy, risk & transactions, technology & transformation and related services to select clients. These firms are members of Deloitte Touche Tohmatsu Limited,...
-
Senior Software Architect, Big Data
1 week ago
Downtown Core, Singapore Rakuten Asia Pte Ltd Full timeSituated in the heart of Singapore's Central Business District, Rakuten Asia Pte. Ltd. is Rakuten's Asia Regional headquarters. Established in August 2012 as part of Rakuten's global expansion strategy, Rakuten Asia comprises various businesses that provide essential value-added services to Rakuten's global ecosystem. Through advertisement product...
-
Downtown Core, Singapore Deloitte & Touche LLP Full time $120,000 - $150,000 per yearCompany description: "Deloitte" is the brand under which tens of thousands of dedicated professionals in independent firms throughout the world collaborate to provide audit & assurance, tax & legal, strategy, risk & transactions, technology & transformation and related services to select clients. These firms are members of Deloitte Touche Tohmatsu Limited,...
Senior Quality Assurance
2 weeks ago
**Join a team that is changing millions of lives.**
Transforming smiles, changing lives.
At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation. Our diverse and collaborative teams are constantly pushing the boundaries of what’s possible.
Ready to join us?
**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.
**Sound like a good fit?**
Great Click the "Apply" link to let us know you are interested. Not the right fit? Don’t worry, Align is quickly grow
