OPERATIONS DIRECTOR, DIAGNOSTICS

OPERATIONS DIRECTOR, DIAGNOSTICS

Be part of the team at Smiths Detection, where technology comes to life!

Smiths is a world leader in the practical application of advanced technologies. Our products and services make the world safer, healthier and more productive.

Smiths Detection, a highly successful division of Smiths Group, is doing work that matters to countless individuals worldwide. In addition to complete security solutions encompassing trace detection equipment, x-ray screening systems and other proven and developing technologies, we offer incredible career opportunities.

SUMMARY OF ESSENTIAL FUNCTIONS:

The primary objectives will be to establish cGMP manufacturing and supply chains and to implement and maintain Quality plans, for instruments and consumables to the required standard for FDA approval and CE marking in the newly created Smiths Detection Diagnostics business.  The Operations Director will use his/her industry experience to establish operational excellence in both Smiths and third party suppliers, including recruitment of a dedicated team of specialists to undertake all operational activities, and establishment of facilities for manufacture.  The Operations Director will assume global responsibility for operations once the business is established.

SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Manage the Day to day aspects of the manufacturing process, including product configuration, procurement, materials management, production planning & control, manufacturing engineering, production and dispatch and track all tasks to completion ensuring that production targets are met on time, to cost, and to expected quality requirements.
• Maintain an operational readiness plan that includes production schedule, COGS estimate, resource forecast etc,
• Ensure facilities are correctly managed and utilized, and that Health and Safety Management is implemented effectively, ensuring that environmental and Health and Safety issues are compliant with current legislation and Group policies.
• Maintain, monitor and audit Quality Procedures at all sites and suppliers. Perform due diligence assessments and qualification audits maintaining KPI reports ensuring compliance with current FDA and CE requirements
• Act as compliance consultant for the business, revising procedures as required for improvement or for compliance with regulatory authorities
• Create a world class manufacturing operation Identify and implement best practice as part of a continuous improvement initiative, seeking to continually improve manufacturing processes and procedures, yield, margins, and assembly times, as well as minimize supplier lead times
• Develop and manage a world class supply chain for both PCR reagents and hardware system components.
• Work closely with the R&D Department to ensure that the design control process meets the required quality standard, and represent operations in the management of DFM procedures
• As part of the management team, make significant contributions to the overall running of the business unit, and participate in formulation and implementation of the strategic plan
• Implement a manufacturing strategy which strives to deliver maximum efficiency and quality, and update this strategy on a continuously rolling 5 year basis.
• Comply with and ensure department compliance with Company health, safety and environmental policies.
• Comply with all applicable U.S. export control and security regulations.
• Other duties as required.

POSITION REQUIREMENTS:

• B.Sc. or MBA in Life Science/Quality/Engineering with at least 15 years of post-graduate experience in a relevant industrial environment, showing progression to management in an operational setting covering high volume manufacture of IVDs or medical devices, preferably including both instruments and reagents.
• Detailed understanding and demonstrated practical experience of the implementation of, and compliance with relevant quality systems such as ISO9001, ISO14001, ISO13845:2003, 21 CFR Part 820 is essential
• Familiarity with cGMPs and validation principles is essential
• Highly desirable would be Project Management Professional Certification and Six Sigma Black belt certification or equivalent.
• Demonstrated leadership ability with a record of successful relationship partnering and team management in a global context
• Excellent written and oral communication skills, with an ability to motivate and persuade a very broad range of audiences
• Able to work in a broad context where both technical and business aspects are considered and an understanding of strategy is necessary
• Demonstrated ability to manage and deliver complex projects on time and on budget

WORK ENVIRONMENT:
 
Individual's primary workstation is located in an office environment, where the noise level is low. Individual must be able to travel Internationally.


Our benefits mean you benefit…

• Medical/Prescription Drug Plans • Dental Plan Options • Vision Care Plan • Employee Life/AD&D Options • Optional Spouse & Dependent Life Insurance • Long-Term & Short Term Disability • Flexible Spending Account • 401 (k) with Company Match • Retirement Account Plan • Paid Time Off • Tuition Reimbursement • Gym-Membership Reimbursement • Employee Assistance Program • Credit Union • Corporate Discount Programs.

To find out more and to explore our career opportunities, visit us at :


DIRECT LINK HERE...

http://www.smithsdetectioncareers.com/na/index.php?p=viewjob&job_id=1999&refer=13

Must be a US Citizen and eligible for a US DoD Security Clearance. Smiths Detection, is an equal opportunity employer and does not discriminate on the basis of race, color, sex, national origin, religion, age, physical or mental disability, veteran status or any other basis protected by applicable federal, state or local law in the terms or conditions of employment, programs or activities. Individuals with questions regarding this policy or self-identification form are encouraged to contact Human Resources.

www.smithsdetection.com