QA and Technical Documentation Officer

The Leather Market

10 Nov 2022

The Leather Market

Quality Assurance

Full Time

1

3 years

The Company

Machine Medicine Technologies (MMT) uses computer vision and computational statistics to enhance the neurological assessment of patients. Our first product, KELVIN, allows assessments of motor dysfunction conditions to be performed, recorded and used both faster and better than has ever previously been possible. KELVIN is already in use at clinical sites across several countries to support routine patient care and clinical trials. MMT aims to build the platform into a generalized tool for patient selection, surgical planning and device programming for machine brain interfacing, a revolutionary therapeutic innovation.

About you
You are an ambitious and experienced QARA professional with at least 3 years of experience in quality assurance and regulatory affairs in the medical devices industry, particularly medical device design and development. You enjoy learning new things, are solution-focused and happy at the interface of technical, legal and regulatory aspects of product development.

List of primary duties and responsibilities (not exhaustive):

  • Authoring and reviewing medical device technical documentation/DHF/DMR/DHR according to relevant requirements:
    • UK MDR
    • EU MDR (CE Marking)
    • U.S. FDA (Premarket Notifications (510(k))
  • Experience needed in compiling the below technical documentation including:
    • Product specifications
    • Labelling
    • Documentation and verification of design controls
    • Authoring and reviewing development and manufacturing procedures
    • Collating manufacturing records
    • Clinical validation protocols and reports
    • Post-market surveillance and post-market clinical follow-up protocols and reports
    • Compiling and updating risk management documentation (ISO 14971)
  • Liaison between product development, manufacturing, QARA, marketing, HR and legal departments:
    • Coordinate communication as needed to execute QARA tasks
  • Remain up to date on changes to country-specific regulations, updated standards/guidance documents and industry trends.

List of secondary duties and responsibilities (not exhaustive):

  • Maintain and organise the company’s QMS and ISMS including:
  • Compiling new SOPs and policies, updating existing SOPs and policies as needed
  • Management of change control approvals and CAPAs
  • Management of supplier approvals and reviews
  • Preparation and presenting information in management reviews and following up on actions
  • Conducting internal audits, following up on NCs
  • Participate in external regulatory and customer audits
  • Conducting quality and regulatory training as needed
  • May need to carry out quality system administration as needed

Qualifications:

  • Bachelor’s degree in quality management, regulatory affairs or related field (medical, scientific or engineering)

Work experience:

  • Minimum of 3 years experience as a quality/regulatory professional in the medical devices industry

Skills (critical):

  • Experience in quality management systems (ISO 13485 / 21 CFR 820)
  • Experience in compiling medical device technical documentation
  • Ability to independently carry out research and summarise findings
  • Strong written and verbal communication skills
  • Extremely high level of attention to detail
  • Flexibility to carry out various tasks within the QA department according to changing priorities

Skills (desirable):

  • Experience in medical device software validation (ISO 62304)
  • Experience in information security (ISO 27001)
  • Experience in UK DPA, EU GDPR and HIPAA regulations
  • An ISO 9001 / ISO 13485 / ISO 27001 internal/supplier/lead auditor certification will be highly advantageous

Company Benefits

  • 25 days annual leave (+ local bank holidays)
  • Equal opportunity employer and value diversity
  • Offices close to London Bridge, Bermondsey Street and Borough Market
  • Hybrid – 4 days onsite and 1 predetermined day remote per week

Job Reference no. QA099