Quality Engineering Leader Position
This role requires an experienced leader in quality engineering to oversee the development and implementation of our company's Quality Management System (QMS). The ideal candidate will have a strong understanding of industry standards, including ISO 13485 and 21CFR820.
The successful candidate will be responsible for leading cross-functional teams to ensure compliance with regulatory requirements and maintaining our QMS certified status. They will also be expected to develop and implement strategies to improve efficiency and effectiveness within the quality function.
We are seeking a highly skilled professional with a proven track record of success in quality leadership roles. If you have experience working in a fast-paced environment and are passionate about delivering high-quality products, we encourage you to apply.
Responsibilities:
* Lead cross-functional teams to ensure compliance with regulatory requirements
* Maintain our QMS certified status by implementing and improving processes
* Develop and implement strategies to improve efficiency and effectiveness within the quality function
* Collaborate with stakeholders to identify and prioritize improvement opportunities
* Implement risk management and mitigation strategies
Requirements:
* 7+ years of experience in medical device development and/or manufacturing, applying QMS certified to ISO 13485, ISO 9001 or similar
* 3+ years of experience working in a senior role within the quality function of a medical technology company
* Experience working as the Quality Lead on a cross-functional team undertaking a medical device development project
* Experience in managing a team of people (2+ reports), directing and reviewing outputs from quality or other technical personnel
* A demonstrated ability to effectively train people on quality management principles and on how to comply with quality management systems
* A demonstrated ability to perform tasks with very fine attention to detail, demonstrating a passion for efficiency and technical quality in design, development and manufacturing documents, and managing reports to do the same
* Qualification as a lead auditor and experience in undertaking internal and supplier audits
* Experience in undertaking risk management and risk analysis activities, including Hazards Analysis and FMEA
* Experience in undertaking manufacturing planning, quality control and process validation in medical device manufacturing environments
* Demonstrated experience in Microsoft Office suite (required; Excel, Word, PowerPoint, Project)
* A degree in Engineering (Mechanical, Mechatronics, Biomedical), Industrial Design, Sciences or similar applicable technical discipline
Benefits:
* Career progression and a strong mentoring program
* Employee benefits including an employee assistance program
About Us:
We are a global leader in medtech commercialization, with a portfolio of over 500 projects across various industries. Our company values include being resourceful, curious, positive, putting others first, embracing complexity and taking ownership. We strive to create meaningful outcomes for our partners and customers.
Location:
Sydney, New South Wales, Australia
Job Type: Full-time
Seniority level: Mid-Senior level
Industry: Medical Equipment Manufacturing, Business Consulting and Services, and Engineering Services
Keyword: QualityEngineeringManager