The Director of Operations manages Materials, Warehouse, Shipping & Receiving personnel. Works closely with Executive Management Team, QA, Regulatory, Finance and various Engineering disciplines in procurement and supply chain activities. Incumbent works with manufacturing staff, and quality organization and engineers. The Director of Operations will understand and maintain current Obalon manufacturing processes and manufacturing documents.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Assists transfer of new products from R&D to Mfg./Supply Chain
Responsible in managing supplier relations; participates in the selection and qualifications process of new vendors
Manages all Shipping, Receiving and Warehouse responsibilities
Executes Operations goals, monitors, drives actions and reports actual to plan to Executive Management as required.
Initiate, direct and monitor planning practices to ensure data integrity and the utility of ERP system.
Champions and monitors product life cycle/end of life process for manufactured materials.
Ensures compliance with applicable regulations & policies within medical device industry including European, US, Canadian and other regulatory and Quality System requirements (ISO, CFR, SOR, MDD, etc.).
Assists with development of department budgets and forecasting.
Provide analysis in areas of inventory accuracy, inventory levels against targets, On Time and Shipping, minimization of waste and scrap, and supply chain cost, quality and delivery performance.
As a leader in the organization maintains the highest safety standards for his/her areas of responsibility and acts as a role model in supporting the Safety, Health and Environmental policies and standards of the company.
Ensures proper training has been provided prior to employee performing job functions.
Follow European, US, Canadian and other regulatory and Quality System requirements (ISO, CFR, SOR, MDD, etc.).
Be an expert on manufacturing of Obalon products to specifications, fulfilling all quality requirements and manufacturing requirements as given on the MPI’s and LHR. Identify production process issues or manufacturing process changes to improve efficiency or reduce production scrap. Work with engineering and quality to implement changes.
Train and teach others on the manufacturing processes and quality system requirements. Maintain all training records
Learn and practice JIT and Lean Manufacturing techniques where possible.
Work adhering to European, US, Canadian and other regulatory and Quality System requirements (ISO, CFR, SOR, MDD, etc).
Manage Warehouse Operations to ensure proper handling / safeguarding of inventory
Oversee monthly cycle count program or annual physical inventory to ensure accurate inventory balances
Work with finance to ensure proper inventory valuation, including partnering on standard cost setting, evaluation of potential excess and obsolete materials and scrap tracking
Work with finance to forecast inventory levels and expense for annual / interim budgeting purposes
This position assumes and performs other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Experience with Microsoft Dynamics Great Plains (Inventory, Manufacturing and RMA modules).
Extensive knowledge of ERP applications in medical device or other regulated industry.
Working knowledge of cost accounting and labor reporting
Working knowledge of Demand Planning and Supply Chain forecasting
Strong Logistics experience
Working knowledge of Microsoft Office or equivalent
Experience with Product Lifecycle, Document Management and/or Quality Management software is highly desirable
EDUCATION and/or EXPERIENCE
BA or BS degree required
APICS CPIM or CPSM desirable
Previous management experience required within medical device industry
5 or more years of experience
Experience in Global Quality Systems (i.e., ISO13485, QSRs) and Medical Device Regulations (CFR, MDD, SOR) as it relates to department and job duties described within this document.
Experience working with Hazardous Materials
Excellent communication skills and ability to work with people of differing capabilities.
CERTIFICATES, LICENSES, REGISTRATIONS
APICS CPIM or CPSM are desirable
Training in JIT and Lean Manufacturing Techniques a plus.
Ninety percent of the manufacturing/production operations take place in a controlled environment room. This means that the individual will be required to gown for the clean room and maintain hygiene (no make-up, nail polish, rings). Controlled environment or clean rooms may be cooler than normal working environments to compensate for the additional clothing/gowning required. The work also can require working through microscopes and operations that require excellent manual dexterity. The work environment may require limited lifting, usually no more than 25 pounds. The work environment may have chemicals or materials that require personal protective clothing/equipment to work safely.
While the position is also an office type position there will be travel and visits to vendors and suppliers. This position may operate fork trucks, pallet jacks, and other pieces of material handling equipment.