QA & Regulatory Affairs Officer

QA & Regulatory Affairs Officer
Greater London / Hybrid working
£35K - £50K pa - depending on experience.

Who are we?

Sparca was born out of award-winning imaging software provider, AOS, in 2018.

The AOS Anterior solution is transforming the ophthalmic industry, using its 400+ algorithms to create better images, extract more information and analyse more data.

Sparca exists to help organisations across multiple sectors achieve advanced imaging, to optimise signal processing and to correlate data. Whether we facilitate the upgrade of current technologies or assist in creating new ones, our mission is to transform digital signal processing.

We build our applications dependent on client requirements and these can range from a full desktop solution to a simple single feature API.

We operate in multiple sectors including Security, Biometrics, Medical and Financial Services.

Will you be part of our journey?

Critical capabilities:

  • Writing and reviewing SOPs, Work Instructions, Forms and controlled cGMP and GDP documents;
  • Initiating, reviewing and co-ordinating Deviations, Non-conformances, CAPA’s;
  • Oversight of the Change Management System;
  • Follow up on change control actions with appropriate action owners and drive for on time closure of actions;
  • Prepare monthly metrics;
  • Complete complaint investigations and assist with close out of complaints;
  • Perform cGMP internal audits;
  • Assist in the performance of external audits (as and when required);
  • Work to the requirements of ISO13485:2016 and promote and implement the processes required within that QMS;
  • Work within the framework CFR Part 11.820;
  • Familiarity with multi regulatory markets globally;
  • Responsible for executing training for quality and other relevant persons;
  • Assist with preparation for customer/regulatory audits;
  • Assist with audit requests during customer/regulatory audits;
  • Prepare response to customer audits;
  • Host/attend cross departmental meetings as required as quality representative;
  • Identify and support opportunities for improving processes and or procedures;
  • Assist in continuous improvements projects for procedures and processes;
  • To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities;
  • Familiarity with MDR 745/2017;
  • Experience with electronic records and electronic document control;
  • Knowledge of audit trail and data integrity requirements in the medical device sector;
  • Knowledge of software used in the medical device sector; for example, change management systems, document control systems, databases, validated spreadsheets etc.;
  • Experience with software validation.

Essential Requirements:

  • Ability to start as soon as possible;
  • Experience with software validation;
  • BSc in Life sciences or Quality;
  • Auditor training would be an advantage;
  • Experience of communicating and organising with a variety of staff;
  • Experience of working in an office environment and/or working with a remote team;
  • At least two references;
  • Minimum 4 to 5 years’ experience in a medical device industry.

Personal Qualities:

  • Highly motivated and proactive;
  • A collaborative team player;
  • Calm under pressure; flexible, friendly and helpful;
  • Discreet with an understanding of the need to maintain confidentiality;
  • Tactful and diplomatic;
  • Ability to adapt to the changes within the project and the deadline and to prioritise multiple tasks.

Benefits:

  • Between £35,000 and £50,000 per annum, depending on experience.
  • 25 days annual leave (excluding bank holidays).
  • Annual discretionary bonus.
  • PerkBox, Private Medical Insurance and Pension.

Send your CV and covering email to careers@sparca.com or apply on Linkedin.

USA
Sparca Corporation, Inc.
401 East Las Olas Boulevard
Suite 1400
Fort Lauderdale,
FL 33301

UK
SPARCA Ltd,
Davis House, Robert Street,
Croydon,
Surrey,
CR0 1QQ,
United Kingdom

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