Description
Job Summary
In this role, you will be 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.
Essential Duties And Responsibilities
- Ensures the quality of the parts produced by inspecting parts visually, ensures relevant documentation is recorded and signed off in real time.
- Maintaining accuracy of batch documentation at all times and ensuring that it is filled in and right first time.
- Completing measurements as required by the work instructions, reviewing measurement results and alerting 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 general 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.
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
- 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 ISO 13485:2016.
- Other duties as assigned.
Additional Responsibilities
Education
- High School Diploma or GED preferred
Work Experience
- Previous production work experience would be an advantage.
- Knowledge of Good Manufacturing Practices (GMP) requirements would be an advantage.
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 organizational skills.
- Must be able to work in a team environment.
- Basic knowledge and understanding of a computer.
- Must be willing to work in a controlled environment, which involves the wearing of a gown, cap and relevant personal protective equipment.
License and Certifications
Travel Requirements
5%: Up to 13 business days per year
Physical 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.
