Trendlines Medical Singapore – Quality Assurance Executive
We are looking for Quality Assurance Executive to join Trendlines Medical Singapore located in Singapore.
Here’s your chance to create the future with us!
Trendlines Medical Singapore operates through investing in, incubates, and provides a range of critical services to nurture and support Singapore-based entrepreneurs and start-up companies in the medical device sector from development to commercialization in the global market.
More about us and our portfolios: https://www.trendlines.com/business-units/medical-singapore/
- Setup and Implement ISO 13485 QMS and 21 CFR Part 820 QSR management systems across multiple portfolio companies.
- Serve as Quality representative on project teams for new product commercialization processes.
- Follow up and review risk assessments, design verification and validation test reports; ensure compliance with established procedures and sound validation methodology
- Review and approve manufacturing operational activities, such as Device History Records (DHR), supplier qualification, manufacturing transfers, nonconformance, CAPA and customer complaints
- Work with cross-functional teams to resolve operational quality issues
- Define and implement supplier’s key performance indicators, ensure consistency in supplier quality
- Work closely with suppliers to trend, analyse and improve quality issues and escalate to supervisor/management as necessary
- Lead internal and external audits, ensuring system compliance and resolve non conformities
- Ensure the quality systems meet external and internal requirements and any other related requirement within the Quality Management System
- Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO third party audits
- Other such duties that may be determined by Supervisor
- Bachelor’s degree in Engineering or Biological/Life Sciences
- More than 3 year’s experience in a medical device product development environment.
- Excellent interpersonal, verbal and written communication skills
- Ability to apply knowledge to 21 CFR 820 and ISO 13485 requirements
- Strong analytical, problem-solving and decision-making skills; Certified Quality Engineer, or equivalent, is a plus
- Experience in managing compliance with relevant stakeholder, across different level of people
- Familiar with managing supplier’s manufacturing quality metrics
- Knowledge of Document Control structure and its implementation
- Proficient in computer systems such as Microsoft Office
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