About the role
As the Quality Manager at APS Medical Technology, you will be responsible for overseeing and ensuring the quality of our medical device products. You will play a crucial role in our scale-up phase, both establishing and maintaining our ISO 13485 Quality Management System (QMS). This role has a strong focus on managing our internal quality, and our critical suppliers of animal tissue.
About you
You are a proactive problem-solver with a pragmatic approach to quality, capable of prioritising and implementing effective solutions quickly. You love to work collaboratively within a cross-functional team, and you are comfortable with both strategic QMS development and practical on-the-ground quality activities.
What you'll be doing
* QMS Leadership
* Develop, implement, and maintain a fit-for-purpose ISO 13485 Quality Management System that evolves with business growth.
* Monitor key quality metrics and report QMS effectiveness to senior leadership.
* Supplier Quality
* Establish quality agreements with suppliers and conduct audits, including abattoirs, ensuring compliance with ISO and APS specifications.
* Internal Oversight
* Oversee incoming goods inspection and internal quality records management.
* Participate in external audits and internal quality investigations (non-conformances, CAPA).
* Continuous Improvement & Training
* Identify quality issues, conduct root cause analysis, and implement corrective/preventive actions.
* Deliver training to internal staff to embed a strong quality culture.
* Contribute to cross-functional initiatives and support ad hoc quality activities as needed
What we're looking for in a successful candidate
* Hands-on experience in quality management - Demonstrated autonomy in conducting supplier audits and managing quality assurance processes for raw materials.
* Comfortable visiting and inspecting our supplier sites (abattoirs)
* Proven ability to develop and manage a QMS in a fast-paced, growing company.
* Strong interpersonal skills and the ability to communicate quality requirements across diverse teams.
* Experience with various quality subsystems (e.g., document control, CAPA, supplier quality).
* Prior exposure to external audits, understanding auditor expectations.
* Pragmatic, iterative approach to quality, with strong problem-solving and communication skills.
* Willingness to travel for supplier site visits.
* Technical background (e.g., Engineering, Science) is highly beneficial.
* ISO 13485 training and familiarity with relevant regulatory requirements (e.g., ISO 22442, ISO are a plus.
What we offer
At APS Medtech, we are dedicated to creating a positive and supportive work environment that empowers our employees to thrive. We offer a range of benefits, including competitive remuneration, opportunities for professional development, and a flexible work arrangement to help you achieve work-life balance.
About us
APS Medtech is a leading medical device company that specialises in the design, manufacture, and distribution of innovative animal derived products. With a strong focus on quality, innovation, and customer satisfaction, we are committed to advancing patient care and improving clinical outcomes. Join our dynamic team and be part of our exciting journey.
If you're ready to lead quality in a growing MedTech environment, we'd love to hear from you.