Manufacturing Process Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeMANUFACTURING Full time $106,328 - $157,219

We are seeking a Manufacturing Process Specialist to join our team. The ideal candidate will have at least 8 years of experience in a highly regulated GMP manufacturing environment and a strong understanding of quality management systems. Key Responsibilities:
• Maintain efficient and productive engineering support to manufacturing and repair areas through implementation and management of day-to-day manufacturing/repair issues and process improvements.
• Provide solutions to identified manufacturing & repair problems, analyzing and resolving complex manufacturing, quality, and compliance issues (e.g., CAPA, non-conformances, audit observations).
• Ensure NCRs, CAPAs, concessions, and change notes are processed in a timely manner, using proven methods to analyze failures and challenges, identify root causes, and implement solutions for yield and quality improvement.
• Collaborate with other departments (warehouse, supply, procurement, NPI) to resolve manufacturing challenges, reviewing product, process, and equipment designs, work instructions, and safety to meet business needs without compromising quality.

Requirements:
• At least 8 years of experience in a highly regulated GMP manufacturing environment, preferably with minimum Bachelor's degree in Electrical Engineering, Technical, or Manufacturing qualification.
• Experience working within a Quality Management System is highly desirable, as well as experience with production management systems (e.g., Oracle), Design of Experiments (DOE), developing protocols, and performing process validations (IQ/OQ/PQ).
• Experience in designing process flows and production line layouts is a must, along with exposure to a regulated environment working within a QMS framework; ISO exposure or good understanding of QMS is also a must. Strong project management skills, especially in process improvement and cost-saving projects, are an advantage.

Benefits:
At our organization, we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees. We aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to reach their full potential. Through our internal programs and employee benefits, we strive to create an environment where our people feel valued and supported.

About Us:
We are the global leader in implantable hearing solutions, with over 600,000 devices helping people of all ages lead active lives. Our mission is to help people hear and be heard, empowering connections and transforming the understanding and treatment of hearing loss. We innovate and bring to market implantable hearing solutions that deliver lifelong hearing outcomes.

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