Assembler I
Humacao, Puerto Rico Design / Civil engineering / Industrial engineering
Job description
Position Description
Operates under extremely well defined procedures and policies under very direct supervision. Works is well defined and repetitive in nature. Performs various assembly processes and/or record keeping processes, acquire quality awareness of the job task, and identify various components of an assembly as appropriate. Maintains an expected level of attendance, attitude, and teamwork. Work is performed applying GMP standards and guidelines.
Position Responsibilities
· Produces devices that have the maximum level of quality that can be achieved based on the product and process design.
· Prepares processes, cleans installs, assembles reworks, verifies, tests, solders, and/or inspects components, hardware, subassemblies, and assemblies on single or multiple product lines.
· Adheres to environmental and safety procedures associated with production processes and procedures.
· Works from prints, drawings, method sheets, diagrams, workmanship standards or other specifications in accordance with established assembly and inspection procedures.
· Monitors and records related documentation to meet quality requirements.
· Follows production build rates, schedules and meets time and quality standards.
· Achieves and maintains “qualified operator” status in one or more manufacturing processes.
· Maintains a thorough understanding of the acceptance criteria for the specific operation(s) being performed.
· Demonstrates the understanding and significance of line clearance and other Good Manufacturing Practices (GMP) procedures/ and Quality System Requirements.
· Accurately documents information on history records, inspection data sheets, scrap reports, and other documentation related to specific processes being performed.
· Actively participates in the daily cleaning of CEA, dressing rooms, and other housekeeping tasks.
· Complies with all CEA protocol, including personal hygiene, gowning procedures, and safety procedures.
· Demonstrates the ability to work as a team member in a manner that is conducive to a positive work environment.
· Understands the clinical, cosmetic, and / or processing relevance associated with the acceptance criteria and the implications of substandard quality.
· Communicates to your supervisor immediately If any situation interrupts department optimum efficiency.
· Complies with company policies, procedures and rules.
· Performs other related duties as required.
Quality Responsibilities
· Reports any observed or informed process and/or product non-conformities to the Supervisor for action and resolution.
· Reports any complaint regarding a Medtronic product to the Supervisor.
· Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System Regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR’s).
EHS Responsibilities
· Acknowledge and maintain commitment with the EHS Policy.
· Participate in the development of EHS improvement projects.
· Participate actively in the EHS programs to achieve the objectives and targets defined for the area.
Minimum Education
High School Diploma or equivalent
Basic Qualifications
Background
· Educational: High School Diploma or equivalent
Experience:
Associate Level: 0 year with High School or equivalent
· Additional requirements as per site and business needs
· Exposure to manufacturing environment
Skills
· Interpersonal Relations
· Quality and Results Oriented
· Computer Literate
· Basic oral and written communication skills in Spanish and English
Desired/ Preferred
Qualifications Background
· Experience in medical device, pharmaceutical, or electronic industry
Skills
· Problem Solving
· Teamwork
· Communications
· Continues Improvement
· Ability to adapt training methods to match trainees learning style