Help shape the future of orthopaedic innovation, ensuring precision, compliance, and excellence at every step as a Senior Quality Systems Engineer at Enztec.
About Enztec: Enztec is not just shaping the future of orthopaedic instruments; they're pioneering innovation with precision and passion. As a leading global medical device manufacturer, Enztec's commitment to excellence drives every aspect of their work. From their cutting-edge design processes to their unwavering dedication to customer satisfaction, they're revolutionising the orthopaedic industry one instrument at a time. With a passionate team of experts and a culture of collaboration, Enztec is where innovation meets craftsmanship, and where every individual contributes to their collective success.
About the role: As a Senior Quality Systems Engineer, you'll lead efforts in ensuring Enztec remains the gold standard by driving quality, meeting regulatory and customer obligations, and steering day-to-day delivery operations and continuous improvement of the Quality Management System (QMS). You will engage with passionate individuals in the medical device industry and become a pivotal member of this enthusiastic team by applying your deep understanding and expertise in the regulatory and industry standards field. Key accountabilities for this role include:
Continue the implementation of the new eQMS and lead the transition to MDSAP certification.
Execution of and maintaining ongoing compliance with global standards across Enztec.
Ability to interpret and articulate relevant regulatory requirements while documenting clear, concise processes and reports that comply with the associated standards ensuring continual maintenance and updates.
Identify and respond to non-conformance and CAPA issues.
Investigation of root cause issues while leading complex problem-solving initiatives that drive systemic improvements.
Facilitate cross-functional communication across the Quality and Regulatory team and wider business departments.
Production and presentation of high-level reports relaying quality improvement initiatives to internal and external stakeholders.
Lead risk management initiatives in accordance with SOPs and industry standards.
Conduct internal audits and lead external audits from both regulatory bodies and customers.
Craft, review and manage submissions of required documentation for adverse event reporting and product recalls.
Develop and lead training programs for the Quality and Regulatory team and wider Enztec team.
About You: As an experienced quality engineer, you will understand the significance of forging strong relationships with all those you work with. You will have a curious approach that embraces best practice initiatives while keeping up to date on global regulatory standards and can quickly adapt to new systems and processes. Key qualifications include:
3-5 years' experience in a quality management role within the medical device industry.
A tertiary qualification in Science or Engineering.
Expertise in working with ISO13485, EU MDR, FDA CFR, ISO14971, and ISO10993.
Experience conducting internal audits against ISO13485 and MDR.
Outstanding communication and interpersonal skills, with strong listening abilities.
A clear, concise writing style and the ability to relay technical processes and documentation in a manner that is understood by various audiences.
A proven record of successfully managing complex projects and initiatives from inception to completion.
A pragmatic approach and appreciation for giving and receiving constructive feedback.
Expertise in fostering a culture of continuous improvement and innovation ensuring that those you work with are empowered to contribute their ideas and drive positive change.
A proactive approach and effective planning capabilities with the ability to prioritise and meet/exceed deadlines.
Strong technical capabilities within the Microsoft suite and eQMS (experience in MasterControl would be advantageous).
Commitment to promotion of and upholding a safe, inclusive and medically sanitary work environment that upholds compliant ethical standards.
If you have the expertise to be part of a team pushing the boundaries of next-generation orthopaedic instruments and medical devices, while ensuring strict compliance and enjoying the process, we invite you to join us on this exciting journey! Applications close on the 3rd of November 2024. If you're ready to join a team who punch well above their weight, please forward your CV and cover letter outlining why you believe you are the Senior Quality Systems Engineer we are looking for to ****** - alternatively reach out to Nikkie for a chat about this opportunity.
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