Quality Administrator

Hologic

  • Cambridge
  • Permanent
  • Full-time
  • 1 month ago
Job Category: Quality & Regulatory AffairsDegree Level: Not IndicatedJob Description:Join Endomag, a Hologic Company, and Help Shape the Future of Medical Devices!Are you passionate about quality, detail-oriented, and eager to make a difference in healthcare technology? At Endomag, a Hologic company, we're on a mission to improve the standard of care for cancer patients worldwide. We're looking for a talented and driven Quality Assurance Administrator to join our dynamic team and help us uphold the highest standards in medical device quality.What To Expect:The main function of this role is to work with other internal parties to maintain the Quality Management System through management of the documentation which forms the QMS. This role will involve communicating with our departments to maintain compliance through our Work Instructions and Procedures. Other functions within this role will involve support functions to the Quality and Regulatory team, Logistics and Supply Chain and ensuring that suppliers continue to adhere to acceptable quality standards via the audit process and tracking of products with end users, (via distribution partners if applicable) where it relates to product quality and post-market surveillance.
  • Documentation control to ensure implementation of changes to procedures within the QMS and technical files as standards evolve
  • Work with the Senior QA Compliance Administrator to maintain the document control module within the eQMS.
  • Assist in facilitating changes to work instructions, forms, procedures and technical file documentation ensuring changes to any documents or processes are well documented.
  • 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
  • Assist with both internal and external audits
  • Assist with maintaining the CAPA and SCAR process within the eQMS.
  • Ensure activities meet and integrate with organisational requirements for health and safety, legal stipulations, environmental policies and general duty of care.
  • Ongoing training for specific daily functions will be discussed during check in
What We Expect:Qualifications
  • Experience in QA/QC administration is the main consideration
  • Auditing experience to 13485 and MDSAP would be advantageous
Experience and Knowledge
  • 2-5 years' experience in ISO quality systems for medical devices
  • Evidence of experience working in a busy and demanding environment within a team and able to work individually.
  • Good IT skills (MS Office)
Abilities and Skills
  • Self-starter with strong motivational skills
  • Good written skills, demonstrated in a range of contexts
  • Evidence of effective communication and inter-personal 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
  • This is a hybrid position, you must be located and willing to be present on site. You must also be willing to occasionally travel within the UK if required.
Ready to Make an Impact?If you're looking for a role where your work truly matters, and you want to be part of a team that's passionate about making a difference, we want to hear from you!
  • Innovate with Purpose: Work at the forefront of life-changing medical technology.
  • Collaborative Culture: Join a friendly, supportive team where your contributions matter.
  • Personal Growth: Expand your skills in a fast-growing, global company.
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Hologic