Senior Quality Systems Administrator

2 months ago

Cambridge, United Kingdom Endomag Full time

Job Title: Senior Quality Systems Administrator (Maternity Cover)

Contract: Full-time

Contract Type: 12 month’s fixed term contract.

Location: 330 Cambridge Science Park Milton Road, Cambridge, CB4 0WN

Hybrid: Two days on site

Responsible to: Senior QA Compliance Officer

Key working relationships: COO, QA Director, QA & RA Compliance Manager QA/RA team, Regulatory Consultants

Background:

Endomag is the global technology company that believes everyone deserves a better standard of cancer care. Many of the world’s leading physicians and hospitals use our magnetic-based technologies to help women with breast cancer avoid surgery when it isn’t needed, and experience better outcomes when it is. Using our Sentimag® probe, physicians are able to accurately stage breast cancer with our Magtrace® lymphatic tracer and perform tissue localisation procedures with our Magseed® marker.

So far, our team has helped over 500,000 women around the world access more precise and less invasive breast cancer care.

The purpose of the role:

The main function of this role is to ensure ongoing improvement of the eQMS and continued compliance. Other functions within this role will involve support functions to the Quality and Regulatory team, liaising with various departments in a busy and dynamic environment.

 

Key Responsibilities and duties:

  • Responsible for the company’s electronic ISO 13485 quality system, providing ongoing maintenance, configuration and implementation of new processes, and validation activities.
  • Support in documentation control to ensure implementation of changes to procedures within the QMS and technical files as standards evolve.
  • Ensure effective maintenance of the company’s training records.
  • Assist in managing quality procedures across supply chain partners and manufacturers to ensure maintenance of standards.
  • Assist the team to ensure quality audit actions are completed in a timely manner.
  • Maintenance of documentation for future products related to quality assurance processes and maintain records for compliance and auditing purposes.
  • Support and maintain the release process, for new product release to customers, logging and maintenance of repairs and complaints and associated tasks.
  • Support the QA Director and QA/RA Compliance Manager during audits by Notified Body or other organisations as required.

Requirements

Qualifications

  • Previous experience of configuring eQMS systems or systems platforms within a pharmaceutical or Medical Device environment is the major consideration.
  • Experience with pharmaceutical or medical device Quality administration is advantageous.
  • Degree or equivalent in computing/engineering/Life Science or closely related field.

 

Experience and Knowledge

  • 1-5 years’ experience in ISO quality systems for pharmaceutical or, ideally, medical devices.
  • Evidence of experience working in a busy and demanding environment within a team and individually.
  • Good IT skills (MS Office) are required.
  • Experience configuring eQMS and implementing electronic systems is preferred.
  • Experience with validation of software platforms is desirable but training will be given.
  •  

Abilities and Skills

  • Self-starter with strong motivational skills.
  • Good written skills, demonstrated in a range of contexts.
  • Evidence of effective communication and interpersonal skills.
  • Evidence of ability to work with critical attention to detail and high levels of accuracy.
  • Proven organisational and time management skills to effectively handle conflicting priorities and ensure tight deadlines are met.
  • Experience in working for a small, dynamic organisation

Other

Willingness to occasionally travel within the UK

Benefits

Pension: Non-contributory pension scheme, Endomagnetics contribute 9% of base salary, the employee contribution is discretionary.

Private Medical Insurance: For you and family.

Dental insurance: For you and your family.

Employee Assistance Programme: For you and your family (includes access to a virtual GP)

Discretionary Annual Bonus Scheme: payments up to 10% of salary.

Life Assurance: Death in service benefit (4x base salary).

Additional Health: Company eye tests and flu vaccinations.

Holiday: 25 days annual leave.

Your birthday Off: 1 day of paid leave per year for your birthday.

Annual Leave Buy Scheme: purchase up to 5 five days leave, in addition to your usual annual leave allowance.

Volunteering Leave: 2 days of paid leave per year for you to volunteer for a charity.

Paid Time Off for Dependents: 2 days of paid leave per year to deal with an emergency relating to your dependents.

Paid Time Off for a Domestic Emergency: 2 days of paid leave per year if you need to deal with a domestic emergency.

Maternity and Paternity: Enhanced maternity and paternity leave package.

Group Income Protection: Up to 75% of salary for periods of long-term sickness absence.

Environment: Pleasant working environment including a wellness room, spacious break out and lunch area with quality coffee and fresh fruit.

Facilities and Access: Vehicle and cycle parking. Positioned within easy walking distance to Cambridge North Rail Station.

This role is reserved for candidates with full right to work in the UK without sponsorship.

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