Applies skill and dexterity in the assembly of components used to produce devices, in keeping with regulatory and company guidelines.
Key Responsibilities:
- Operate assigned equipment and has proficiency in operations: lasers, welders, knitters, autoclaves, kitting, ironing, and final packaging and labeling.
Also work on one of the following: sealers, in-process packaging, labeling, ID tag processing, washers, ultrasonic cleaners, or ovens in order to assure appropriate settings and parameters, including selecting and utilizing fixtures and aids associated with assigned operation in the manufacturing of components, working at a level of greater independence with advanced level of quality and productivity.
- Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, GMPs, GDPs, including recording traceable information on device history records and may enter information into JDE.
- Perform line clearance, i.e., cleaning and sanitizing work stations at the start of the shift and when transitioning to next work orders.
Self-assessment of work, sequential review of colleagues work, and providing constructive team feedback
- On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period
- Other incidental duties: General work area housekeeping, material handling, printing, support production lines and other task assigned by the supervisor related to the operations.
Education and Experience:
H.S.
Diploma or equivalent 2 years years experience of previous related experience Required
Other: previous GMP, clean room, medical device experience Preferred
Additional Skills:
- Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
- Ability to use required hand tools, hand eye coordination, and high manual dexterity
- Ability to understand and follow complex work documentation, using strict attention to detail
- Ability to perform repairs on nonconformance errors
- Good communication skills
- Elementary-level understanding of numerical functions
- Basic computer skills required
- Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures
- Must be able to work with minimum supervision by following detailed manufacturing instructions
- Ability to effectively provide and accept feedback from colleagues based on sequential work reviews
- Work in a Team environment, primarily with colleagues and supervisor
- Successful completion of ongoing job training of assembly process steps
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control