Production Specialist

5 months ago

Macquarie Park, Australia Saluda Medical Full time

**About Saluda Medical
Saluda Medical was founded in 2013 for the purpose of transforming patients’ lives with disruptive neuromodulation solutions. We are leaders in the field with proven exceptional pain management results and, with more than 10 years of advanced research development and clinical experience, we design and develop advanced neuromodulation systems for the next generation of implantable stimulation devices.

**What We’re Looking For...
Working within our Manufacturing team, as our **Production Specialist **you will be responsible for:

- Creating and managing change configurations to manufacturing processes, documentation, and tool information, as well as monitor & coordinating Arena (PLM system) change workflows activities through stages 2 & 3, by collaborating with relevant production stakeholders.

Supporting and collaborating with the Production Trainer, Senior Production Line Supervisors, and Production Support Specialist to achieve daily production output and efficiency, resolving production issues and problems as they arise.

**Your role will include:
- Plan & implement changes following the change control procedure, ensuring that change scope, rationale, and supportive information are clearly documented and explained to stakeholders.
- Engage collaborators and reviewers to address and resolve any issues and minimise delays in review and approval processes.
- Liaise with all relevant stakeholders to implement and transfer configuration and operational details between key systems (e.g. Arena and QAD).
- Carefully define change scope and establish plans for the completion of all key change activities, including but not limited to (a) change dependency assessment (b) inventory disposition assessment (c) PWO transition plan & annotation, and (c) change tickets.
- Monitor the progress of all changes impacting production, specifically the required actions for Arena stages 2, and 3 and change completion. Actively follow up on current or emerging delays.
- Track (daily) the status of change review status, and change ticket completion, and escalate any concerns about constraints, priority conflicts, or other issues that require resolution.
- Assist in the implementation and improvement of standard operating procedures (SOPs) and work instructions (WIs) used to build Saluda products. Incorporate the non-conforming report (NCR) process for physical dispositions, repairs, or rework and complete appropriate reporting and documentation.
- Support and collaborate the required production related NCRs, from containment, and investigation to disposition stages.
- Provide support to Production Trainer, Senior Production Line Supervisors, Production Support Specialist, and Production Operators.
- Provide administrative support when required (SOP, QAD, Arena, and ADP systems).
- Comply with all Saluda Medical policies, rules, and guidelines as well as relevant Quality processes and procedures.
- Participate in department and project/team meetings.
- Rotation to other job-related areas within the company for cross-training.
- Maintain a tidy and safe workplace and storage areas.
- Maintain good team relationships within the company and with our suppliers. Other duties required from time to time directed by your manager.

**About you:
- Solid knowledge & experience driving and managing processes and continuous improvement.
- Strong time management skills, attention to detail, and accuracy in completing daily tasks.
- Strong work ethic with high levels of initiative, demonstrating the ability to plan and prioritise to meet, at times, tight deadlines under pressure.
- Strong interpersonal and communication skills.
- Ability to handle multiple priorities and develop strong relationships with customers, fellow employees, and suppliers.
- Ability to facilitate and manage change input from cross-functional stakeholders.
- Strong organisational skills and a demonstrated ability to independently manage multiple tasks and priorities under time constraints.
- Proven computer literacy with specific skills in MS Excel and MS Word. Experience with product lifecycle (and change) management systems (e.g. Arena Application) and business systems (e.g. QAD ERP).

**It’s not essential, but nice if you have:
- A Bachelor of Engineering or equivalent.
- Experience with product lifecycle (and change) management systems (e.g. Arena Application) and business systems (e.g. QAD ERP)
- Knowledge of regulatory requirements and experience with working in a quality-controlled environment. Lean Six Sigma certification.

**At Saluda, we challenge boundaries. We innovate and think beyond the conventional. **We disrupt.
**Are you Ready to Join? **If you would like to be part of our team developing the world's next generation of implantable device technology, contribute to making an impact on patient care, then this is the opportunity for you Please **APPLY NOW

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