Job Description
Quality Assurance Officer
At Corza Medical, our mission is to support surgical providers with remarkable service, trusted performance, and outstanding value by creating an unmatched experience that stems from listening to the surgical experts themselves.
Blink Medical Ltd is part of the global Corza family, we are a leading provider of single-use instruments & procedure packs for use within ophthalmological; dermatological and general surgical procedures. We aim to champion and aid surgical providers with remarkable service and exceptional choices. We are a continually growing business of 60 employees based in Shirley, Solihull
What we value:
Integrity. We do what is right.
Accountability. We do what we say.
Customer First. We deliver extraordinary experiences.
One Global Team. We before me, always.
Inspired. We love what we do.
What you will do:
As a Quality Assurance Officer, you'll report to the quality Director and be responsible for supporting the routine management and continuous improvement of the Quality Management System in accordance with the requirements of ISO 13485:2016 and all other applicable regulatory requirements.
Some of the key responsibilities of the Quality Assurance Officer will involve the following:
• Reviewing, writing and updating SOP's (standard operating procedures) to ensure compliance with business practices and relevant international standards and guidelines.
• Performance of internal audits to determine compliance with the relevant international standards (inc. ISO 13485:2016).
• Identification and implementation of process improvement techniques.
• Leading on non-conformance reports, including the management of corrective and/or preventative actions (CAPA's).
• The establishment and monitoring of quality metrics (key performance indicators).
• providing support and guidance to the operational team on change control, new product introduction, procedure packs, sterilisation processing and regulatory compliance.
What you will need:
• Experience of working within a quality assurance role, ideally within a medical device company and educated to a degree level.
• Experience of working with ISO 13485:2016 is essential.
• Ideally you'll have worked with quality system auditing and taken the lead on the management of non-conformances.
• Strong organisational skills with a systematic approach to tasks and the ability to prioritise.
• Good analytical and problem-solving skills, with great attention to detail.
• QMS Auditor Training would be a distinct advantage.
• Great team spirit; we're a small team you'll need to be prepared to get involved in whatever it takes to get the job done.
In return we offer:
• A salary of £30-40K per annum (dependent on experience)
• 33 days annual leave (including Bank Holidays).
• Healthcare cash plan
• Group Life Assurance of 4 x salary.
• Group Income Protection.
• Employee Assistance Programme - with free access to a GP, counselling & legal advice for you and your household
Hours of work:
Our working week totals 38.5 hours per week our core business hours are Monday - Friday 08.30-17.00.
What you will like:
We foster a work environment where all team members are empowered and encouraged to share their opinions and ideas. We encourage robust, fact-based debate. Our highly collaborative work environment results in the best decisions for Corza Medical and a shared mission to execute our plan together, on time and on budget.
Join our team:
At Corza Medical, we are motivated by enabling our customers' success. That starts with understanding their needs and developing products that enhance clinical outcomes. Our goal is to provide innovative, high-quality products and services that will ensure the continued success of our company and surgical professionals well into the future.
Equal Opportunity Employer, including disabled and veterans.