Job Summary
Working under supervision and following detailed verbal and written instructions, performs repetitive line assembly operations to produce medical device products. Associates are required to wear special garments while working in the controlled environment area (CEA). Group Leader is expected to have (or to obtain) certification in every process in assigned production area. Knowledge of SAP opening and closing orders. Is a leader in daily/weekly production meetings. Entrusted to cover production when the supervisor/manager is out and fill in on the production line as needed.
Job Details/Responsibilities
- Safety – knowledge of each process and the ability to detect unsafe situations and practices and act.
- 5S – knowledge and application of Lean Manufacturing principles for a neat and orderly workspace
- Daily Line set-up, ensuring tools, supplies, materials, and documentation are available for the scheduled run.
- Identify, communicate, and respond to potential problems with materials, tools, etc. in a timely manner.
- Manage the daily activities to meet productivity and quality objectives, and are to drive line performance improvement on an ongoing basis (promoting ongoing continuous improvement)
- Assign tasks and procedures for the line – continuous workflow of product (ensures product is moving through the line and/or personnel are where the work is)
- May participate in disciplinary action, performance/merit reviews, and general assignments and changes to assignments.
- Line quality system compliance, including all applicable documentation, floor policies, auditing, assessment of the need for training, etc. He/she is responsible for the compliance of the lines’ equipment calibration and maintenance.
- Train Assemblers and ensure adequate documented training exists, acceptable levels or understanding are present, and assemblers and operators comply with all training requirements.
- Performance management – identifies areas of concern and provides/secures additional training as required.
- Promotes cross training and job rotation.
- Assists with creation of staffing plan based on goals and takt time.
- Access resource needs (i.e., labour, equipment, etc.) and make recommendations when additional resources are required to ensure product availability.
- Coordination of periodic Physical Inventory activities for his/her line or area.
Job Responsibilities (continued)
Working Conditions/Physical Requirements
QUALITY REQUIREMENTS:
- Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
- Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
- Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.
EH&S REQUIREMENTS:
- Take care of your own health and safety and that of others who may be affected by your actions.
- Work co-operatively to highlight issues affecting Environmental Health and Safety
Knowledge, Skills and Abilities (KSA)
- Aptitudes: Strong English communication skills (written and oral) to effectively communicate expectations, plans, interpret and train others to controlled documentation, specifications, procedures, etc.
- Strong organizational skills to allow effective and efficient management of the direct labor, materials, schedules, etc.
- Temperament: Ability to perform a variety to tasks, often managing multiple issues/priorities at the same time.
- Knowledge: Must be competent in their work area as well as having knowledge of other functional areas in the room.
- Workflow: Demonstrates an exceptional understanding of production processes and DHRs.
- Preferred proficiency in SAP and Inventory management.
Qualifications/ Background Experiences
- 5+ years’ experience of direct medical device manufacturing or related industry
- 1+ years in a supervisory/group lead role
- Have good understanding of quality system requirements (e.g. 21CFR820, ISO13485), as well as all required Quality System documentation and record procedures.
- Working knowledge of measurement techniques and quality standards.
- Basic math skills
- Basic PC skills and utilize common word processing and spread sheet software.
- Work well with all departments of the company.
- Able to work closely with Assemblers and gain/maintain their respect.
- Able to communicate with Engineers
