LetsGetChecked
LetsGetChecked is a leading at-home health testing company, with a platform that allows consumers to discover and access personalised health information conveniently, confidentially and accurately. We empower people to take an active role in their health to live longer, happier lives. LetsGetChecked was founded in 2015 and has corporate offices located in New York City and Dublin.
Quality Assurance Supervisor
Reporting to the Quality Manager the successful candidate will supervise all aspects of the Quality Assurance Team.
Responsibilities:
- Lead and manage a group of Quality Assurance Technicians, while ensuring high GMP standards are maintained and adherence to production plan and targets to meet regulatory and business requirements.
- Work closely with the manufacturing, inventory, and shipping teams by providing guidance/ organise training sessions on the relevant quality procedures applicable for the product and monitor amp; coordinate the activities of the rework product.
- Document procedures and work instructions, perform process failure mode effect analysis and support with any risk management activities, as applicable.
- Communicate to management on product quality issues via site reporting structure e.g. meetings, formal reports, etc. and assist with internal and/or external audits.
- Report Quality metrics to the management and leading and influencing positive change initiatives in the team e.g. continuous improvement initiatives, lean six sigma, NPI etc.
- Continuous management and appraisal of the performance and development of Quality Assurance Technicians in accordance with site continuous learning pathways.
- Be comprehensive and concise in written and oral communications, including documenting on-hold notices, quality alerts and drafting daily meeting minutes.
- Build positive relationships with a variety of internal stakeholders in a cross-functional team environment.
What we’re looking for
- Bachelor's/Master’s degree preferably in Science, Quality, Engineering or related field with 3-4 years of experience in quality assurance department in a medical device or pharmaceutical industry.
- A self-starter, able to work on own initiative, handling multiple conflicting priorities within tight timeframes and contribute to high-quality effort on a daily basis.
- Great attention to detail with good interpersonal skills and communication skills, combined with strong organizational skills.
- Critical thinking skills with an ability to analyse information and data from a variety of sources to make a data driven decision for troubleshooting and resolving problems/issues.
- Possess good knowledge on ISO 13485:2016, EU-MDR, IVDR, US-FDA 21 CFR Part 820 and other applicable regulations.
- Expertise in process of verifying the quality of products produced, incoming inspection of raw materials by ensuring that they are in accordance with the applicable procedures, specifications and meet appropriate acceptance criteria.
- An understanding of Quality Management module in SAP is an advantage.
- While some supervisory or managerial experience is expected, candidates may be considered who have demonstrated leadership skills, including the ability to organise and manage the work of a team to achieve objectives and to encourage others to reach their full potential.
Why LetsGetChecked?
Together we have a common goal to help people live longer, happier lives.
We want our employees to be healthy, travel often, and have the financial resources and support they need to live a fulfilling life, both inside and outside of work. We encourage our employees to build their careers at LetsGetChecked. We run regular career training clinics, interview assistance, and encourage employees to apply for internal opportunities. We support Learning amp; Development through our partner Udemy.
Diversity, Equity amp; Inclusion
As we continue to grow, LetsGetChecked is fully committed to creating an inclusive environment where diverse backgrounds, perspectives and experiences are valued, where each and every one of our people feels that they belong and are empowered to do the best work of their career.