Department: Quality
Location: APAC-Singapore
Description
Role summaryThis position is ideal for mid level QA professional to join the International Commercial QA team as a Commercial QA Specialist or Manager,
6 months contract, driving effective Quality Management System to comply with medical device regulatory requirements and Align's internal requirements. Partnering with cross functional teams from commercial sites, you'll provide QA expertise to establish and maintain site's QMS. This role is to ensure importation and distribution activities of the Align's commercial sites adhere to regulatory guidelines and support overall business continuity.
Role Expectations
- Support the Director of International Commercial QA in developing and maintaining QMS procedures to comply with local regulatory requirements and Align Global Quality Framework, Global QMS Policies and Global Standard Operating Procedures, working with business partners to develop an efficient and compliant QMS for importation, storage and distribution of Align's products.
- Conduct / Support NC/CAPA, complaint investigations, internal audits and Quality metrics reporting.
- Ensure compliance with QMS and regulatory requirements for assigned projects.
What we're looking for
- Education: Bachelor Degree in Science or Engineering preferred.
- Experience: 2-3 years in medical device Quality Assurance role.
- Skills: knowledge of GDP, ISO 13485:2016; certified ISO 13485:2016 auditor will be a plus
- Communication: Excellent written, verbal and interpersonal communication and presentation skills.
- Teamwork: Ability to work both independently and collaboratively. With a high standard of integrity, open mindedness, open communication, respect and business ethics.
Complementary skills
- Ability to thrive in a fast-paced environment and adapt to changes.
- Ability to research and propose well-thought-out solutions when dealing with challenges.
Key Responsibilities
Role Expectations
- Support the Director of International Commercial QA in developing and maintaining QMS procedures to comply with local regulatory requirements and Align Global Quality Framework, Global QMS Policies and Global Standard Operating Procedures, working with business partners to develop an efficient and compliant QMS for importation, storage and distribution of Align's products.
- Conduct / Support NC/CAPA, complaint investigations, internal audits and Quality metrics reporting.
- Ensure compliance with QMS and regulatory requirements for assigned projects.
Skills, Knowledge & Expertise
What we're looking for
- Education: Bachelor Degree in Science or Engineering preferred.
- Experience: 2-3 years in medical device Quality Assurance role.
- Skills: knowledge of GDP, ISO 13485:2016; certified ISO 13485:2016 auditor will be a plus
- Communication: Excellent written, verbal and interpersonal communication and presentation skills.
- Teamwork: Ability to work both independently and collaboratively. With a high standard of integrity, open mindedness, open communication, respect and business ethics.
Complementary skills
- Ability to thrive in a fast-paced environment and adapt to changes.
- Ability to research and propose well-thought-out solutions when dealing with challenges.
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Equal Opportunity Statement
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.
