Careers

Maintain manufacturing of medicals devices, assist with Quality to maintain GMP is being followed. Manage inventory and be able to solve inventory issues. Track and prepare inventory items for purchasing. Create production documentation and reconcile inventory items. Packaging of product and supporting the shipping and receiving activities. Coordinate products for international shipment and domestic shipment. Assist other departments as needed.

• Maintain sufficient stock for future production builds.
• Manage logistics of Incoming and Outgoing Stocks, Domestic and International
• Create and update BOM’s.
• Maintain a clean and presentable warehouse.
• Maintain the clinical inventory.
• Manage the material requisitions.
• Storing raw material and FG in the correct locations. 
• Create work orders.
• Provide input for production schedule.  
• Accept additional work-related projects as assigned.
• Planning materials and placing purchase orders.

• High School Degree or Equivalent
• Five (5) years of experience in working in a Production & Inventory Management environment
• Experience with an electronic inventory system is strongly preferred (ERP)
• Experience with assembly of electronic hardware (ESD)

Skills – Technical

• Knowledge in utilization of Microsoft Word, Excel, Outlook and Internet applications.
• Proficient in the use of inventory software (SAGE 100, ERP).
• Possess specific knowledge of company’s range of products and services
• Ability to interpret and explain inventory reports
• Ability to effectively manage time to meet required deadlines
• ISO 13485 / 9001 / GMP

Skills – General

• Be a self-motivated individual with strong communication skills
• Work professionally with colleagues and be a team player
• Maintain flexibility with work projects
• Complete work in a timely, accurate and thorough manner
• Positive attitude, courteous, honest and reliable.
• Ability to read and understand complex documents.
• Strong problem solving and decision making skills
• Lead by example
• Ability to follow regulations

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computer terminals.

Assist in maintaining the Medical Device Quality Systems and assure continued compliance with FDA GMP / QSR regulations along with European standards to include ISO 13485 and MDR EU 2017/746

• Assure manufacturing is performed and documented to GMP requirements; US FDA Quality System Regulation, MDR EU 2017/746 and ISO 13485.
• Assure Design Control Documentation complies with appropriate regulations (QSR, GMP, ISO, Etc.).
• Assist in the oversight of Quality Engineering to assure Design Control Documentation complies with appropriate regulations (QSR, GMP, ISO, Etc.).
• Perform QSR activities as well as lead Quality group to complete those activities (CAPA, complaints, audits, training, labeling, etc.)
• Perform document Control to include Change Order System, Label Control, Quality Records (LHR, NCMR, Service Records, etc.) and associated Archived Records.
• Oversight of Quality Control Activities: Incoming and In-process inspections, Environmental Monitoring, storage, shipping and distribution records, PM records, and SPC (statistical process controls).
• Maintain Quality Assurance Program: calibrations, training, internal and external audits, vendor qualifications, Risk Management per ISO 14971, CAPA, complaints, MDR and Vigilance Systems, and supplier ratings.
• Prepare for and assist with audits from external regulatory authorities to include FDA
  investigators, notified bodies and State and local regulatory authorities (California FDB) during on-site audits.
• Sterile product experience (steam, e-beam, ETO, gamma, eBeam) and principals of statistical process control, and statistical Quality Control preferred

• A Bachelors degree in Engineering, Bioengineering, or Life Sciences required. Electromechanical device experience desirable, experience in a medical device manufacturing environment, experience with FDA investigators and/or ISO Auditors is a plus.

Skills – Technical

• Detail oriented and computer literate in PC MS word processing, Excel spreadsheets, and
  databases.

Skills – General

• Be a self-motivated, customer-oriented person with excellent communication skills
• Work professionally with colleagues and be a team player; maintain flexibility with work projects
• Complete work in a timely, accurate and thorough manner
• Think and work both tactically and strategically to provide operational needs to Cytori’s business
• Ability to read, write and analyze complex documents
• Respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, colleagues and outside constituents
• Strong problem-solving, judgment and decision making skills are required

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computer terminals. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.