Assembler 2, Instrument - Katalyst Healthcares & Life Sciences
San Jose, CA 95131
About the Job
Responsibilities:
- Performs instrument assembly by following released procedures.
- Must be able to read and understand assembly instructions, work orders, Bills of Materials, Standard Operation Procedures, and all other documentation used to control our products and processes.
- Confers with engineers, technicians, production personnel, and others regarding assembly procedures.
- Must have the ability to create and maintain productive working relationships within the work team and with other functions.
- Collaborates with peers to achieve shared departmental goals.
- Keep work area clean organized and safe.
- Fill out time sheets and all other required paperwork accurately and on time.
- Keeps training file up to date at all times.
- Ability to effectively communicate information and respond to questions both verbally and in writing.
- Good mechanical aptitude, dexterity and hand/eye coordination.
- Must be able to reach, bend and lift 35 lbs. on a daily basis.
- PC or MAC user, familiar with: Word, Excel, and Windows.
- Must be willing to be trained in other areas of production where the skill level requirements may be lower.
- Knowledge and adherence to safety procedures and programs
- Occasionally, this position will also require assisting packaging base on business needs.
- Responsible for the manual inspection, labeling, and packaging of clinical and commercial products.
- Perform finished product packaging as required to satisfy all customer, internal, clinical, and other demand.
- Ensure finished product is packaged in accordance with procedures and Quality specifications.
- Inspect in-process packaging, components to ensure consistent quality and remove defective products and packaging material.
- Perform routine cleaning of packaging station and processing equipment.
- Abide by all personal protective equipment and product contamination control (i.e., gowning) requirements.
- Handle hazardous waste as appropriate. Work well in a team environment.
- Good documentation practices.
- Must be willing and able to work a flexible work schedule including static or rotating shifts and overtime as required.
- Requires a High school or GED degree.
- Ability to effectively communicate information and respond to questions both verbally and in writing.
- Good mechanical aptitude, dexterity and hand/eye coordination. Must be able to reach, bend and lift 35 lbs. on a daily basis.
- Experienced PC or MAC user, familiar with: Word, Excel, Windows and/or MAC OS
- Knowledge of PC's and networking environments
- Must be able to follow established methods and procedures in performing ex: assembly of optical, mechanical, fluidic and/or electronic components, assemblies, and testing.
- Experience working in a medical device manufacturing organization.
- 3+ years related experience in a high tech, manufacturing environment.
- Experience with Excel, Visio, Power Point
- Knowledge of ISO 9000, cGMP 21 CFR part 820 or FDA
- Performs electro-mechanical assembly and sub-assemblies for medical device products.
- SAP experience preferred.
Source : Katalyst Healthcares & Life Sciences