Job Purpose:
Fulfil quality assurance responsibilities for new product development and post-market activities within the sustaining engineering team (i.e. commercial product support), including:
* Demonstrating and promoting a commitment to improving patient safety, customer satisfaction, and product quality.
* Understanding and complying with the organisation's quality, business, and health & safety systems, as well as applicable market and legal regulations governing quality systems.
* Identifying, removing, or mitigating risks associated with the design, use, and manufacture of medical devices.
* Ensuring commitment to required training and understanding and complying with all regulations governing assigned work.
Key Responsibilities:
General
* Completes work assignments under limited supervision and guidance.
* Interfaces with cross-functional teams including R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres, and Post-Market Quality Assurance, providing technical and quality systems input.
* Demonstrates familiarity with requirements and procedures governing medical device Design Control, Risk Management, and Post-Market Surveillance.
* Identifies and resolves complex exceptions within work assignments.
* Supports continuous improvement in product and process quality.
* Builds quality into all aspects of work by maintaining compliance with all quality requirements.
* Demonstrates excellent interpersonal and communication skills, with strong leadership capabilities.
Technical
* Provides both quality and technical input to post-market commercial product activities.
* Experienced in post-market (complaints) support, risk management, design and process change, and standards compliance with regulatory requirements.
* Provides design quality support in the resolution of product investigation reports (PIRs), complaint investigations, CAPAs, vigilance issues, and regulatory requirement changes.
* Demonstrates excellent analytical and problem-solving abilities.
* Analyses data, draws conclusions, and makes appropriate decisions based on risk management activities and test data.
Leadership
* Acts as an active team member, completing quality deliverables associated with sustaining engineering and post-market support activities.
* Uses project assignments as opportunities to develop self and others.
* Demonstrates strong motivation and consistently applies best practices in line with agreed objectives.
* Willingly implements changes within project and departmental practices.
* Supports a culture of continuous improvement and constructive challenge to achieve best-in-class performance.
Qualifications & Experience:
* HETAC Level credits) qualification in a STEM discipline, with a minimum of 3–4 years' experience in a similar role.
* Strong technical capability, communication skills, teamwork abilities, and initiative.
* Proven ability to work effectively both as part of a team and independently, with minimal supervision.