Head of Quality Assurance
Role Overview:
This role is for a unique opportunity for an ambitious, proactive, entrepreneurial-minded driven individual that is capable of wearing multiple hats and thrives in high-paced environments. As the Head of Quality Assurance, you will lead all aspects of quality management, compliance, and regulatory affairs pertaining to our product. Your primary responsibility will be to establish and maintain a robust quality management system (QMS) to ensure the safety, effectiveness, and reliability of our product and develop the technical documentation to support the CE-mark and FDA submissions. You will collaborate closely with the company’s CTO and product team to uphold quality standards throughout the product lifecycle, from design and development to manufacturing and distribution.
Company Overview
Polari Group is a VC-backed startup based in London, UK. Polari is pushing the frontier of sexual health innovation and building the world’s first platform for anorectal health and pleasure. Our team develops category-defining products to make the preparation for anorectal intercourse spontaneous and hassle-free. Anorectal health has been overlooked for too long and Polari Group is here to change that.
More about Polari Group:
Website https://www.polarigroup.co.uk/
Polari Group Pitch Video https://www.youtube.com/watch?v=sNjCDDov6gg&ab_channel=EntrepreneurFirst
Articles: Polari’s bold move into anorectal health, Femtech Insider; Opinion piece on anal douching - Why am I posting about anal douching on Linkedin.
https://femtechinsider.com/polari-group-anorectal-health/
https://www.polarigroup.co.uk/articles/whyiamtalkingaboutanaldouchingonlinkedin
Polari Group’s Story:
Anna and Henry met in April 2023 when both of them joined Entrepreneur First, a start-up accelerator that selects exceptional individuals to build their next company.
Before the inception of Polari Group in July 2023, both of them quickly realized that they shared the same belief: they saw an opportunity to transform the world in the areas of medical innovation where most people saw taboo. They also realized that they were both part of LGBTQIA+ community and had a world-class combination of complementary technical and operational skills to design and commercialize new medical technology.
Today Polari Group has received funding, set up a lab in central London, developed the functioning product, filed the patent for their technology and are working with the world’s leading experts in anorectal health in the UK and US. They have developed and engaged a community of future customers that cannot wait to get the product in their hands.
About You:
You are ambitious, proactive and entrepreneurial-minded
You are passionate about changing the status quo and bringing a revolutionary sexual health and wellness product to the market
You live and breathe quality
You have excellent project management skills
You are comfortable with high-paced environment and change
You have excellent communication and people skills
Your responsibilities:
Quality Management System (QMS) Development and Maintenance:
Develop, implement, and continuously improve the QMS in accordance with applicable regulatory requirements, such as ISO 13485.
Provide oversight for the design and development activities, in accordance to the relevant quality standards (e.g. ISO13485, FDA 21 CFR 820)
Establish and monitor quality objectives, key performance indicators (KPIs), and quality metrics to drive continuous improvement and ensure product excellence.
Conduct internal audits, risk assessments, and management reviews to assess QMS effectiveness and identify areas for enhancement.
Regulatory Compliance:
Serve as the primary liaison with regulatory authorities, notified bodies, and regulatory consultants to ensure compliance with all applicable regulations and standards.
Prepare and submit regulatory filings, including 510(k) submissions, CE marking applications, and other regulatory documentation as required.
Stay abreast of evolving regulatory requirements and industry trends to proactively address compliance challenges and mitigate risks.
Monitoring of the relevant regulations (including, medical devices, labelling, market authorisation, etc.) for the target markets.
Quality Assurance and Control:
Establish and oversee quality assurance processes, including incoming inspection, in-process inspection, and final product release, to ensure conformance to specifications and standards.
Implement appropriate quality control measures, such as statistical process control (SPC), to monitor product quality and identify deviations or non-conformities for corrective and preventive action (CAPA).
Manage non-conformity investigations, root cause analyses, and CAPA activities to address quality issues and prevent recurrence.
Supplier and Manufacturing Quality Management:
Collaborate with suppliers and contract manufacturers to establish quality agreements, specifications, and performance metrics to ensure the quality and consistency of raw materials, components, and finished products.
Conduct supplier audits and assessments to evaluate supplier capabilities, quality systems, and compliance with regulatory requirements.
Monitor and evaluate manufacturing processes to identify opportunities for process improvement, efficiency enhancement, and risk reduction.
Qualifications:
Bachelor's degree in engineering, life sciences, or a related field
2-3 years of experience in quality assurance, quality engineering, or regulatory affairs within the consumer medical device industry, preferably with Class 1 medical devices
Strong knowledge of quality management systems, regulatory requirements (e.g., FDA, ISO), and standards relevant to sextoys and medical devices.
Proven track record of successfully managing regulatory submissions, audits, and inspections for consumer medical devices.
Excellent communication, leadership, and interpersonal skills, with the ability to collaborate effectively across departments and influence stakeholders at all levels.
Detail-oriented, analytical mindset with the ability to solve complex problems and drive continuous improvement initiatives.
Experience of production control plans and process validation (using IQ / OQ / PQ methodology)
Ideally but not required:
Experience working in sexual health and wellness space
Experience working with regulated consumer goods in sexual health and hygiene space, anorectal health (E.g. tampons, condoms, anal suppositories)
Benefits:
Growth - You will be the second employee of the company, get a high level of ownership of the role, work closely with the founders and Polari Group’s advisors and supporters.
Meaning - you will work on a meaningful product that will improve the quality of life for +290M people and help shape the next sexual revolution, like the pill did in the 60s, viagra in the 90s and PrEP in the 2010s.
Variety - No day is the same at Polari Group.
Opportunity - Be an integral part of a startup's journey from its early stages, contributing directly to its growth and success, and shape the direction of a cutting-edge company in sexual health changing the status quo.
Culture - We operate on honesty, transparency and consent. We take our work seriously without taking ourselves too seriously. If you share these–this is the place for you.
Location
London, UK
Our take on Diversity
We’re an equal-opportunity employer. We will consider all applications equally regardless of a person’s race, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, background, marital status, disability, or gender identity. Moreover, we actively encourage individuals from groups traditionally underrepresented in the tech space to reach out.
How to Apply
If you are ambitious, passionate about quality, compliance, and making a meaningful impact in the sexual wellness industry, we invite you to join our team as the Head of Quality Assurance. Together, we will uphold the highest standards of product quality and safety while empowering individuals to enhance their intimate experiences with confidence and peace of mind.
We are looking forward to receiving your application.
Please fill in this form to apply https://docs.google.com/forms/d/e/1FAIpQLSebqE-6YlK2oENFbn-HHC34pE1qME-NkLOBsJ4-_gySUPFbTQ/viewform?usp=sf_link
In the end of the form, attach your CV, motivation letter and diplomas compiled in a single pdf document.
Only fully documented applications (Google Form, CV, motivation letter, diplomas) will be considered for the recruitment process.
If you should not hear back from us within two weeks, your application has unfortunately not been successful for this role.