The purpose of an Assembler role is to perform all duties and responsibilities in a safe manner in accordance with all
Smiths Medical procedures. Assembling medical device products within the guidelines of GMP while ensuring the
safety of you and your teammates is a priority. Maintaining a work cell environment that is safe, organized, and
Duties and Responsibilities: (Safety – Quality – Productivity)
Position Description & Requirements:
- Work in a clean and controlled environment ensuring areas are maintained as clean and controlled. (5S)
- Build / assemble a quality product safely according to written procedures.
- Understand Material Safety Data Sheet (MSDS) & Job Safety Analysis (JSA) knowing their locations.
- Perform necessary exercises and job rotations to support a safe working environment.
- Escalate safety/ quality/ productivity issues to Assembler II, Production Operator I / II, or Supervisor.
- Meet and adhere to Lot traceability/label control/cross-contamination requirements.
- Follow approved procedures and operate within validated parameters.
- Assemble components, place product in pockets or packaging.
- Perform production operations proficiently - achieve cell productivity and quality goals.
- Work all positions within a work cell and rotate as necessary.
- A reasonable amount of overtime as determined by production management is required.
- Effectively communicate with team members.
- Participate in teams to continuously improve production processes and product quality.
- Perform visual or other inspection of components to ensure product quality.
echnical Knowledge and Skills:
Planning and Decision Making:
- High School Diploma or equivalent preferred.
- Successfully complete manual dexterity assessment.
- Good hand-eye coordination & Ability to grasp small objects.
- Read, write, and comprehend English.
- Understand verbal and written instructions as required.
- Work cooperatively in a team-based environment.
- Ability to learn and understand the work environment (work cell)/equipment/material handling requirements.
- Participate as part of a self-directed work team based on daily production schedules and customer requirements.
Daily production management by Operations Management, Supervision, or designated work cell leader. Production direction provided by
written standard operating procedures.
Work is routine and must be performed according to established procedures and in accordance with FDA GMPs and ISO 9000 quality
Impact and Scope:
- Assembler I errors are generally detected by another operator on the line or through in process Quality Control inspection.
- Ability to work as a team and a person’s daily attitude impacts the performance of the team.
This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented proc
(including but not limited to FDA, Quality Systems Regulations
, ISO 13485, ISO 14001
, government occupational health and envi
regulations and statutes).
Smiths Medical - 18 months ago
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