FOR INTERNAL SILK ROAD MEDICAL EMPLOYEES TO APPLY ONLY
Summary: Performs various duties as related to the manufacturing, packaging and labeling of Silk Road Medical Products and Sub-Assemblies. Assists Production Management in scheduling and employee training and deployment.
- Assist the Production department by completing assigned tasks which may include:
- Creation and closure of production work orders in QAD system. May work with Finance to resolve issues as needed.
- Assist with managing the lot assignment and completion for all production LHRs (Lot History Records).
- Assist with coordinating the Production Schedule and daily Production Floor activities in compliance with cGMPs and ISO requirements.
- Assist with managing the overall production build plan as assigned.
- Coordinates efforts of various cross-functional groups to resolve Production Floor issues.
- May serve as departmental representative with other departments for problem resolution and production reporting.
- Ensures cross-training and process certification of employees are regularly implemented.
- Participate in productivity projects as assigned.
- Coordinates with Material Control to ensure components and consumable materials are available when needed.
Minimum Qualifications, Experience and Skills Required:
- A minimum of 4 years of experience in a manufacturing/operations environment with a minimum of 1 year of leadership experience
- Basic knowledge of computer applications such as MS Outlook, Excel, and Word.
- Thorough knowledge of QAD transactions within production.
- High school diploma or equivalent.
- Previous work experience in medical device assembly and GMP environment is a must.
- Knowledge of QSRs for Medical Devices.
- Experience with material handling, material non-conformances, and Corrective Action Preventive Action preferred.
- Knowledge of safety procedures used in preventing and addressing injuries
Other Essential Knowledge, Skills and Abilities:
- Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor.
- Ability to read English and to comprehend verbal and written instructions.
- Must be highly organized and able to execute tactics in a timely manner.
- Effective verbal and written communication skills.
- Experience with endovascular medical products and technologies preferred.
- Knowledge of medical industry manufacturing techniques and equipment.
- Working Environment:
- Job duties are typically performed in a Cleanroom environment. Overall duties require the ability to stand or sit for lengthy periods of time. Walking or standing for extended periods of time within the Cleanroom, R&D Lab or warehouse areas may be required for the operation of equipment and assigned duties. The noise level in the work environment is usually low to moderate.
- Personal Protective Equipment:
- The use of specialized equipment requiring additional training will be required.
- The use of Personal Protective Equipment such as Latex/rubber/heat resistant gloves, UV eye protection, safety glasses, goggles, cleanroom gowning wear (smocks, head covers, beard covers, shoes covers) will be required.