Title: Site Operations Manager
Location: Gumtree Remanufacturing Facility
Reporting to: Director Manufacturing Management (based in Thailand)
SUMMARY OF THE JOB:
The Site Operations Manager is required to lead daily operations at our medical device remanufacturing facility, 'Gumtree'. This role is critical in managing the safe, efficient, and regulatory-compliant processing of post-use medical device, classified as waste, into high-quality, remanufactured products. The ideal candidate will bring strong leadership, a deep understanding of regulated manufacturing environments, and a passion for sustainability in healthcare.
In addition, this position plays a key role in ensuring EHS strategies that support the Gumtree operation. These strategies aim to identify, manage, and reduce EHS risks to Cardinal Health employees, facilities, and the surrounding communities, with a focus on continuous improvement and risk elimination wherever possible.
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Manages department operations and supervises professional employees, front line supervisors and/or business support staff.
* Manage day-to-day operations of our remanufacturing facility, ensuring adherence to TGA, FDA, ISO 13485, and other applicable regulatory standards.
* Participates in the development of policies and procedures to achieve specific goals. Ensures employees operate within guidelines.
* Lead and develop a team of floor staff, ensuring proper training in infection control, device handling and ensuring the team operates within guidelines.
* Oversee the intake, decontamination, inspection, and remanufacturing of used medical devices, ensuring traceability and documentation at every stage.
* Monitor production KPIs including throughput, yield, rework rates, and compliance metrics.
* Collaborate with Quality Assurance, Regulatory Affairs, and Engineering to resolve non-conformances and implement corrective actions.
* Drive continuous improvement initiatives using Lean and Six Sigma methodologies to enhance safety, efficiency, and product quality.
* Ensure all waste handling, storage, and processing activities meet environmental and occupational health standards.
* Maintain accurate batch records, device history records (DHRs), and production logs in compliance with Good Manufacturing Practices (GMP).
* Frequently interacts with customers (external) and internal stakeholders such as commercial, functional and regional team members.
Security Responsibilities
* Local point of contact for Global Security.
* Responsible for managing/implementing local security procedures; Access Control, Visitor Management, Key control etc.
* Local Business Continuity coordinator – write/manage local Business Continuity Plans (BCP).
* Report security incidents to Global Security and on to the security incident reporting tool (same tool as EHS).
* Participate in Global Security Coordinator calls.
* Reporting line into the local site leader.
* Liaison with FAST Team (Azam) on status of local security systems; Access Control, Security Camera, Intrusion Alarm etc.
* Conduct annual Security Self-Assessment, requirement for all operational sites and large offices. – this is a set of 30 questions on Intelex and is completed relatively quickly in Q1 each year.
* Point of contact for local Police Dept.
EDUCATION/TRAINING AND/OR EXPERIENCE:
* Diploma or degree in Engineering, Life Sciences, Manufacturing, or related field.
* 8-12 years of experience in a regulated manufacturing environment (medical device, pharmaceutical, or biotech), with at least 1 year in a manager role.
* Strong understanding of ISO 13485, 21 CFR Part 820, and GMP requirements.
* Experience working with remanufactured or reprocessed medical devices is highly desirable.
* Excellent leadership, communication, and problem-solving skills.
* Experience in a corporate multinational organisation is a plus.
* Proficiency in ERP systems and electronic quality management systems (eQMS).
REQUIRED KNOWLEDGE, SKILLS, ABILITIES AND CERTIFICATIONS/LICENSES:
* Lean Six Sigma Green Belt or higher.
* Experience with operations and aseptic techniques.
* Familiarity with environmental regulations related to medical waste handling and disposal.
* Knowledge of ISO 9001 or other quality management systems.
ADDITIONAL POSITION REQUIREMENTS:
Primary work location is in Beresfield NSW. Some travel to our North Sydney office location required.