The quality and regulatory affairs team is responsible for keeping abreast of new, changing and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs, government relations, quality management and market access, to influence with strategic and operational plans.

As a Quality Systems Specialist, you will support business operations to ensure timely resolution of quality issues, while continuing to maintain compliance expectations for non-conformances and associated quality records, with minimal supervision.

What To Expect

Reviews and assesses the appropriateness of non-conformance, planned deviation, and corrective action records in accordance with internal procedures.
Facilitates cross functional meetings such as the Material Review Board (MRB), Product Quality Committee (PQC), Corrective Action Review Board (CARB), etc., as required.
Acts as a Quality contributor for the Product Response Team.
Assists in external audits & Regulatory Body audits.
Serves as QA interface to other departments and/or partners.
Represents QA as a team member on cross-functional special project teams.
Assists in development and maintenance of department Standard Operating Procedures, as needed.
Contributes to a culture of continuous improvement through process improvement activities.
Supports investigations through guidance of quality workflows, trend queries, and other tools.
Performs ERP transactions, as required.
Contributes to the development, maintenance & reporting of department metrics, as needed. What We Expect

Expertise: BA or BS, preferably in engineering/scientific discipline, biomechanical, biomedical, mechanical, electrical engineering etc.
Knowledge - QA experience with a strong emphasis in QSM and Non-Conformances. Experience working in an FDA regulated environment if required
Adaptability: Flexibility to adapt to changing market conditions, customer requirements, and company priorities.
Experience: Working knowledge of FDA Quality System Regulations, ISO 13485, and Risk Management
Skill: Strong communication skills, with the ability to work in a fact paced environment
Autonomy: Demonstrates independent decision making and prioritisation, including independent resolution of conflicts.
Proactive: Ability to anticipate challenges and take initiative to address them.
Resilience: Maintains a positive attitude and strong work ethic even in challenging situations.
Continuous Learning: A commitment to ongoing professional development and staying abreast of industry trends and advancements. Embraces and encourages learning new skills, knowledge and behaviours.Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy