QA Product Release Co-ordinator - Cambridge, United Kingdom - Endomag

Endomag
Endomag
Verified Company
Cambridge, United Kingdom

1 month ago

Tom O´Connor

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Tom O´Connor

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Description

Title:
QA Product Release Co-Ordinator


Base Salary:
£37,000 - £42,000


Location:
Cambridge, UK


Work Structure:
Hybrid, 2 days onsite per week


Key Working Relationships:
QA Director, QA/RA team, Product Engineering, Supply Chain Manager


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 tens of thousands of women around the world access more precise and less invasive breast cancer care.

Now, we're looking for driven team members to help us continue to deliver on our promise and play a critical role in our Quality Team.

If you are passionate about improving cancer care around the world and have the skills to help us make a difference, then we'd love to hear from you.


The purpose of the role:

A necessary part of this role will involve supporting and interacting with the Quality and Regulatory team, liaising with various departments and suppliers in a busy and dynamic environment


Requirements:


  • Support the QA team to maintain the company's ISO 13485 quality system and CE certification.
  • Support and Co-Ordinate to provide guidance to the release personnel, for new build release of
product to customers, logging and maintenance of repairs and complaints and associated tasks.

  • Support with Documentation control to ensure implementation of changes to procedures within the
QMS and technical files as standards evolve

  • Assist in managing quality procedures across supply chain partners and manufacturers to ensure
maintenance of standards

  • Support the QA Director and QA/RA Compliance Manager during audits by Notified Body or other
organisations as required

  • Support the team to ensure quality audit actions are completed in a timely manner
  • Manage customer tracking as it relates to quality of products and postmarket surveillance

Qualifications:


  • Experience in QA/QC to a BS EN13485;2016 level within the Medical Device industry,
(Pharmaceutical industry is the major consideration)


Experience and Knowledge:


  • 510 years experience in QA/QC with a good working knowledge of ISO13485;2016 quality
system for medical devices. Pharmaceutical will be considered.

  • Evidence of experience in interacting/auditing supply chain partners to ensure quality and
timely delivery of products.

  • Evidence of experience working in a busy and demanding environment within a team and
individually

  • Experience with releasing of devices on the market, batch release
  • Good IT skills (MS Office)

Abilities and Skills:


  • Selfstarter 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 under
tight timelines

  • Proven organisational and time management skills to effectively handle conflicting priorities
and ensure tight deadlines are met

  • Experience in working for a dynamic organisation

Other:

Willingness to occasionally travel both the UK and abroad


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 wit
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