Job Summary
Schedule- 12 hr shifts / 8pm-8am and 8am-8pm
Reporting to the Product Group Leader this role is responsible for the production of components that meet or exceed pre-determined specifications. Responsible for inspection, packaging, labelling and completion of documentation necessary to provide quality, production and traceability records in accordance with Quality Systems ISO 9001 / ISO 13485 and Environmental Management Systems ISO14001
Essential Duties and Responsibilities :
- Ensures the quality of the parts produced by inspecting parts visually and dimensionally, ensures relevant documentation is recorded and signed off in real time.
- Maintaining accuracy of batch documentation at all time and ensuring that it is filled in and right first time.
- Records measurement information and alerts appropriate personnel of any deviations from the customer specification or part print.
- Packages the parts according to customer specification and indicates the status of the part (accept / reject) according to proper procedure and specifications.
- Places finished product in correct location.
- Understands and safely operates all equipment.
- Reports and / or corrects unsafe working conditions.
- Performs secondary operations as necessary to meet customer specifications.
- Performs cleaning of machines and ancillary equipment.
- Verifies the labels for correct part and lot numbers.
- Maintains proper level of packaging supplies at each machine.
- Maintains work areas in a clean and orderly manner by practicing good housekeeping.
- Define machine status on OEE System in order to determine machine downtime and run time.
- Compliance to all site Environmental, Health and Safety requirements, training and regulations.
- Compliance to all local site company policies, procedures and corporate policies.
- Act in accordance with the company’s guiding principles and adherence to the corporate Code of Conduct.
- Performs additional duties at the request of the direct supervisor.
- Maintains methods / procedures and all supporting documentation to meet the requirements of Quality Systems ISO9001 / ISO 13485 and Environmental Management Systems ISO14001.
Preferred Knowledge, Skills and Abilities :
Must have good verbal reasoning, numerate ability and mechanical aptitude skills.Must have good communication skills, both written and oral.Must have good organisational skills.Must be able to work in a team environment.Basic knowledge and understanding of a computer.Must be willing to work on a 4-shift basis - The company will operate 24Hrs / day, 7 days / week.Must be willing to work in a controlled cleanroom environment, which involves the wearing of a gown, cap and relevant personal protective equipment.Previous production work experience would be an advantage.Knowledge of Good Manufacturing Practises (GMP) requirements would be an advantage.Physical and Mental Requirements :
Medium – exerting up to 50lb / 22kg of force occasionally and / or up to 20lbs / 9kg of force frequently, and / or up to 10lbs / 4kgs of force constantly to move objects.Requirement to stand, lift and bend.Delegation of Duties :
When absent from the site duties and responsibilities will be delegated to the following designates.
Production Operator