Production Manager

We are an innovative medical device start-up focused on restoring upper extremity function for stroke patients. With a newly qualified manufacturing facility and plans to scale production, we are seeking a Head of Quality Assurance and Regulatory Affairs to ensure compliance and excellence in quality and regulatory practices.

Manufacturing

• Provide mentorship, guidance, and training programs to technicians.
• Oversee employee performance
• Monitor the installation, repair, troubleshooting, and maintenance work carried out by technicians
• Ability to read and interpret technical documentation, drawings, and diagrams.
• Excellent attention to detail, with a focus on quality and accuracy.
• Strong problem-solving skills and the ability to work well under pressure.
• Effective communication and interpersonal skills.
• Ability to work independently as well as in a team environment.
• Manufacturing Experience in the medical device industry

Supply Chain

• Logistics and Inventory Management:
  • SME for the Neurolutions ERP system
  • Efficiently manage the organization's stores facility.
  • Compile order requisitions for processing. Partners with Finance and Warehouse Operations to regularly reconcile inventory with >98% accuracy
  • Executes ERP inventory and sales/revenue invoice transactions
  • May receive goods and services then perform the corresponding transactions in the ERP System
  • Creates new and manages inventory locations
  • Dispositions quarantined, expired, excess, obsolete, and otherwise scrap material
  • May issue purchase orders
  • Updates and keeps material product history records current in the ERP System
  • Authors and trains on relevant ERP and MRP SOPs (Standard Operating Procedures)
  • Ability to manage procurement and supplier relationships that promote a strong product pipeline
  • Supply chain management that maintains quality standards, inventory minimums as well as cost savings targets.
  • Owns and manages all metrics pertaining to order fulfillment
• Safety and Compliance
• • Ensure that all OSHA safety protocols are strictly followed by the team.
  • Implement industry safety practices and maintain compliance with safety regulations
  • Conduct inspections on work orders to verify adherence to safety standards.
• Technical Expertise:
• • Coordinate and motivate teams of technicians in manufacturing or industrial environments
  • Solve line equipment problems and troubleshoot technical issues.
  • Test new products and evaluate their performance.
  • Maintain machinery and perform quality control checks.
• Administrative Tasks:
• • Create schedules for technician shifts and assignments.
  • Handle disciplinary matters when necessary.
  • Generate ad-hoc performance reports.
  • Set up and manage databases and software tools (e.g., test databases, etc)

Education:
A relevant degree, such as a Bachelor's or Associate degree in Technical, Engineering, or a related field,
Strong mechanical aptitude and familiarity with hand and power tools.

Additional Skills

• Execute equipment and process experiment for continual improvement
• Daily support for manufacturing, equipment, process and material as well as current product performance
• Process Improvement projects
• Deliver equipment to improve manufacturing processes automated and semi-automated
• Write and/or execute Validation protocols for new process and equipment
• Troubleshoot manufacturing and R&D equipment and processes
• Carry out duties in compliance with established business policies
• Create a team oriented work environment
• Aid in technology transfer projects from R&D to manufacturing
  • Validation IQ/OQ/PQ/PV
• Physical stamina and the ability to lift up to 25 lbs.
• Support and perform Engineering studies
• Proficiency with Microsoft Office (Word, Excel, PowerPoint,)
• Kaizen & Lean Manufacturing

Please note that the salary information is a general guideline only. Neurolutions considers factors such as the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, and internal equity, as well as location, market, and business considerations when extending an offer.