Are you a motivated Operations Manager with 7+ years of experience leading teams across engineering, manufacturing and facilities? Do you have a passion for driving teams and holding a "The Buck Stops Here" mentality for leading a growing business? If this sounds like you, and you are motivated to work in a regulated field like medical device, apply with your resume today!
You will work closely with the European team (HQ) and report directly to the Group’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.
This role is responsible for the following areas specific to the Virginia site:
• Lead the team Virginia team 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 product line, customer support for direct sales, and related marketing activities including exhibitions/conferences.
• Basic HR duties to ensure the teams needs are met
• 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.
In addition to the above functions and responsibilities employees are required to carry out such other duties as may reasonably be required.
• 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.
• Seven (7) 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
• Three (3) years responsible leadership and management experience with demonstrated success in a complex global organization
• Five (5) years contract manufacturing experience
• Five (5) years Lean, Six Sigma or Continuous Improvement experience preferred
Highly motivated to succeed and passionate about “making a difference”
Open to enlist the expertise of others across the corporation
DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace. We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be. Apply today and experience “The DAVIS Difference”.