Assembler

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PRODUCTION OPERATOR

Purpose & Context

At LivaNova we unite to provide hope for patients and their families through innovative medical technologies, delivering life-changing improvements for the Head and Heart.

As a part of the LivaNova Family you commit to uphold our Mission, Value and Pillars to;
- Put the Patient First
- Meaningful Innovation
- Act with Agility
- Commitment to Quality and Integrity
- Collaborative Culture

Alongside this, your purpose is to successfully assemble Perfusion Tubing System (PTS) Packs to the highest quality and meeting regulatory compliance for the manufacture of medical devices in accordance with organization policies and procedures and Australian Medical Device regulations, ISO 9001 and other relevant statutory requirements - ensuring they are complete on time.

**Responsibilities**:

- Complete your allocated work to ensure production plans including daily volumes are executed and complete according to schedule, escalating as appropriate to ensure remediation activities deliver required outcomes.
- Assemble medical device set as per drawing instructions to the highest quality of product and compliance to all standards and regulations is achieved in the most efficient manner at optimal cost. Ensure all quality checks required are completed.
- Segregate and control assembled jobs to prevent mix-ups.
- Compliance with quality system documentation and ensure documentation and procedures are used as required. Notify Team Leader promptly of all proposed changes in and departures from standard Production processes.
- Support the Team Leader and your team by participating in the review of the following processes:

- Nonconformance reports
- Reprocessing
- Manufactured finished goods complaints
- Preventative and corrective actions
- Maintenance and calibration
- Testing and monitoring Results
- Training needs and identification, including for process changes
- Maintain area cleanliness as per Supervisor’s or Team Leader’s instructions.
- Recommend process and infrastructure improvements that support Right First Time outcomes to ensure we Impress our Customers and Create Business Value. Actively seek continuous improvement for self and all outcomes expected of role.
- Ensure that in-process and finished products are labeled, identified and segregated in Production to prevent errors.
- Ensure stock issued by Kitting is correct stock and quantity per batch paperwork.
- Compliance with LivaNova Occupational Health and Safety (OH&S), Regulatory, Quality and Environmental policies, procedures and work instructions as applicable to this position.
- Assist with training when requested.
- Manage spoilage within LivaNova target and plan to continuously improve KPI.
- Any other reasonable duties as required.

Behavioral Traits
- Respectful of Quality & Operate with Integrity
- Outcome Orientated Focus on achievement
- Dynamic and Forward facing, Engaged with our customers,
- Rich in Knowledge of our industry and Market place
- Entrepreneurial
- Accountable for our actions,
- Act with a sense of urgency
- Encourage communication
- Respectful of People and unified in our direction.

Reporting
- Batch paperwork

Authority to Act
- Applicable LivaNova policies and procedures
- Corporate Guidelines

Skill and Knowledge
- Cleanroom work or production assembly with 3 year’s experience in similar role.
- Effective team member.
- Strong emphasis on attention to detail.
- Good time management skills, ability to prioritise, proactively identify and mitigate risks.
- Ability to read technical information and/or drawings.
- Good problem-solving skills.
- Strong communication (both written and verbal).
- An understanding of production methodology principles including planning, raw materials, quality control, costs, operating procedures.

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