Operations Director – ITL Virginia

Job Category: Manufacturing

Location: Field Based (US)

ITL Group provides true end-to-end design and manufacturing solutions to start ups and OEMs developing life-saving medical technology, diagnostic devices, and scientific instruments for healthcare and life science industries.

For more information about who ITL are please visit our website at :

ITL | Medical Device Company | Design, Development and Manufacturing (itlmedical.com)

ITL Virginia is undergoing unprecedented growth as the site develops from being primarily a post-sales service to also incorporating enhanced assembly, hygiene and logistics expertise.

ITL is part of the G&H Group.

G&H offer exciting and rewarding opportunities for motivated and talented people to join a team of like-minded, highly skilled colleagues who want to grow and succeed with our company.

Hiring talent to complement and grow our current teams’ skills and capabilities is a strategic priority to enable our plans for growth.

Our seven business locations in the United States and four UK-based businesses employ across a broad range of functions including engineering and process, manufacturing, product management, supply chain and customer services, quality assurance, continuous improvement, compliance and finance.

Description

This is a hands-on leadership role in a small but growing facility  where your time will be    split between managing the business and getting involved with the daily operational activities. You will be expected to lead and champion all functional areas, including; supply chain/logistics, manufacturing, servicing/repairs/technical support, QA/RA for the site, facility management, finance, business development with technical input into new projects, sales of the Vitl product line, and program management of ITL Group’s vision for this US-based facility.

You will work closely with the ITL UK team and report directly to ITL’s MD on a weekly basis, via video calls. Additionally, you will be in regular contact with the other functional departments from the UK site, communicating the specific operational activity information and to arrange physical transfer of parts/finished products, in order to meet expected turn-around times and production schedules.

Job Responsibilities

Business

  • Lead the team at ITL Virginia with P/L responsibility for this business..
  • Setting and achieving the gross sales budget and operating expenses in order to meet the Group’s growth targets for the US.
  • Gathering and generating monthly financial information for reporting.
  • Ensuring ongoing state corporation compliance and filings.
  • Oversea the US-Based Business Development Manager, providing assistance with control of the distribution network for the Vitl product line, customer support for direct sales, and related marketing activities including exhibitions/conferences.
  • Basic HR duties to ensure the teams needs are met

Facility

  • Ensure OSHA compliancy and weekly/annual safety checks
  • Ensure site compliance with local authorities (permits, licenses, taxes, etc.)
  • Manage utilities usage, wastage, and the sites impact on the environment
  • Source equipment as required

Manufacturing, service/repair operations

  • Source and arrange the appropriate levels of stock to meet production schedules and RMA turn-around times
  • Manage the team and overall process from parts procurement, goods-in, build, commissioning, DHR generation, release, shipping/logistics, ensuring manufacturing instructions are adhered to.
  • Handle international import/export
  • Report progress/output to the legal manufacturers
  • Play the role of lead engineer/technician as required.

Secondary Duties:

In addition to the above functions and responsibilities employees are required to carry out such other duties as may reasonably be required.

Knowledge, Skills and Experience

  • Bachelor’s Degree in Engineering, Business, or related field; Master’s Degree in related field preferred
  • Professional certification and current active registration with a relevant industry institution/association; PMI, ASQ, RAPS, etc.
  • Ten (10) years Engineering or Operations experience in a regulated industry such as Medical Device, Pharma, LifeScience, etc.
  • cGMP experience, preferably FDA controlled class II Med Dev and IVD.
  • Expert level QMS experience around ISO 13485 and FDA 21 CFR 820
  • Five (5) years responsible leadership and management experience with demonstrated success in a complex global organization
  • Five (5) years CMO experience

Five (5) years Lean, Six Sigma or Continuous Improvement experience preferred

How to Apply

Apply on line or send your resume to Andrew McBride, Head of Global Human Resources at:

amcbride@gandh.com

 

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