Manufacturing Operations Coordinator

The role of the Customer Success Manager is focused on supporting the day-to-day management of the product manufacturing functions with QuantuMDx’s chosen contract manufacturing and product development partners and internal manufacturing, the successful candidate will be working closely with the Operations, QA/QC, Regulatory, and Commercial functions of the business to ensure supply chain demand is fulfilled to the required product quality i.e., ISO 13485, or MHRA, or FDA (similar standards).

A key part of this role will be supporting the Manufacturing Operations Manager in establishing product manufacturing at our partners’ sites, transferring product designs / processes from the QuantuMDx R&D team through to manufacture, and ensuring existing manufacturing activities are maintained and improved.

This role will also interface with the Development and Project Management teams at QuantuMDx, to ensure development needs are supported with respect to manufactured prototypes, against challenging new product development timelines.

The ideal candidate will have proven experience in both manufacturing IVDs/medical device consumables and supporting manufacturing either with CMO(s) or in-house manufacturing, ideally covering processes such as injection moulding of plastics, plastic assembly methods (thermal/laser welding), lyophilised/wet reagent incorporation/handling, packaging methodologies, and/or related product and process quality control, whilst monitoring these aspects using an ERP system.

Key Roles & Responsibilities

Performing a combination, but not necessarily all, of the following duties:

  • A contributor in supporting set-up and monitoring of the Company’s manufacturing operation functions and performance
  • Supporting the Manufacturing Operations Manager in monitoring and reporting on established KPIs for CMOs, incl. follow-up i.e., materials usage, capacity planning, production scheduling, first pass yield, target vs actual cost and safety
  • Driving day-to-day communications with QuantuMDx’s CMO partners to support the Manufacturing Teams on-going production requirements, as well as supporting the internal manufacturing activities and associated validation documents, batch manufacturing records (BMRs), and CoA/CoC generation
  • Supporting the collection, reporting, and presenting of data/information associated with potential new CMO manufacturing set-up projects, in-conjunction with the Manufacturing Function of the team
  • Updating and reviewing existing and new product costings models, leveraging suppliers and the Procurement team to ensure accuracy in instrument and consumable COGs
  • Support New Product Development (NPDs) and Customer Development Projects (CDPs) to ensure new projects enter production in a successful manner and quality, against the Company objectives/timeline
  • Supporting CMOs, in-house Manufacturing, and the development team in assessing product pFMEA, working to de-risk product assembly and delivery.
  • Work with the associated teams to support development of a design suitable for manufacture and assembly (DFM/DFMA), utilising QMDx’s CMO partners for support and guidance here as necessary
  • In conjunction with the Manufacturing Operations Manager, perform review of CMO batch manufacturing reports (BMRs), ISIR/FAI measurement reports, test method validation protocols/reports, GR&R, etc. and supplying feedback to ensure timely resolution and delivery of in-specification product
  • Liaising with internal and external partners to ensure product manufacturing is compliant with ISO-13485 regulations
  • Support writing and reviewing of manufacturing related pre-validation FAT/SAT and validation IQ/OQ/PQ documentation, ensuring products are delivered with complete, reported product, and process validation records in place
  • Ensure suitable capacity manufacturing lines are established and validated for both Q-POC and its disposable
  • Work with the QuantuMDx Commercial team to establish and lock the labelling and packaging specifications for new products, as well as with the development team to ensure material, sub-assembly, and product specifications are captured both for internal manufacturing activities and made appropriate for transfer to QuantuMDx’s CMO partners
  • Maintain external relationships with third party suppliers and partners, CMOs, and CROs
  • Ensure compliance with ISO-13485 and other relevant regulatory standards, both internally and with external parties

Experience, knowledge and requirements

A proven track record of exceeding goals, very bottom-line oriented, and eager to develop further understanding within the area of manufacturing operators.  The candidate should have the capacity to learn quickly when facing new problems, relentless, and have a versatile skillset, ideally being open to change, and someone that enjoys the challenge of unfamiliar tasks.

The successful applicant will have a wide range of stakeholders to appease, both internally and at our CMOs, this will call for excellent communication skills and a structured approach to the tasks at hand, in order to gain commitment from both internal and external parties. QuantumDx’s CMOs and other strategic partners are located around the world, so occasional travel activity could be called for.

Essential

  • Enthusiastic individual with sound technical skills in a relevant industry, analytical ability, and good manufacturing-orientated judgment
  • Some experience in product development and skills associated with developing processes for commercial scale production
  • Previous 2+ years medical device or Pharma consumable industry experience, within the areas of manufacturing and/or process development either in-house and with CMOs / external partners
  • Sound planning and management skills, as well as a capacity to present and relay key timelines, plans, and reports
  • Some experience in problem solving as well as collaborative team-building across multiple geographies, cultures, technical disciplines, and external parties
  • Bachelor’s Degree or higher in engineering, or in a related life science or manufacturing area
  • Ability to work full time in the UK without restriction
  • Good sense of humour and ability to adapt to a changing environment as the Company matures and moves from the R&D stage into commercialisation

Desirable

  • Experience in supporting multiple manufacturing operations to deliver a complex product, i.e., coordination of multi-CMO/supplier assembly
  • Specific IVD device development experience in monitoring/reviewing process development for commercial scale productions
  • History of supporting risk mitigation and costing activities associated with manufacture of products

Company Overview

QuantuMDx is a progressive MedTech company passionate about empowering the world to control disease and reduce suffering. QuantuMDx solves real-world diagnostic problems by creating multiplex molecular solutions for the Point of Need, for anyone, anywhere. QuantuMDx has global operations and strategic partnerships – keeping it at the forefront of molecular diagnostics.

The Q-POC™ platform is a rapid, simple to use, portable, sample to answer multiplex PCR device. It has been designed for use in a range of real-world settings, such as hospitals, clinics, pharmacies, dentistry, workplaces and in the field, providing accurate PCR results at the Point of Need.

Q-POC™ and its first test, a SARS-CoV-2 multiplex detection assay, are CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC), enabling use within Europe. It tests multiple targets of the disease for a future proof COVID-19 testing solution at the Point of Need.

QuantuMDx plans to launch a range of syndromic multiplex testing assays over the coming months and years.

Apply for this role

To apply for this role, please get in touch via recruitment@quantumdx.com, attach your cover letter and CV. Thank you.


We’re an equal opportunities employer. The personal data you supply relating to your employment application will be used in accordance with our Privacy Policy. 

The intent of this job description is to provide a representation and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.