Senior Quality Specialist

Acts as quality delegate and provides direction and leadership to the team(s) and business as required. Effectively partners and collaborates with commercial and functional teams to develop and influence sound products, processes, and business-related decisions. Accepts accountability for delivering and leading core quality projects and value improvement (VIP) initiatives that reduce risk, improve efficiency and add value to the organisation. Leads the business through complexities by applying risk management methodologies to events such as field actions, CAPA's (Corrective and Preventive Action) and other unforeseen quality issues. Accountable for representing quality and providing quality direction to the business during change and growth. Proactively communicates and presents to all levels within the organisation. Implements initiatives and objectives that align with individual or team goals. Establishes and maintains strong relationships internally and externally. Contributes to a culture of respect, diversity, and inclusion. Courage Confronts problems directly, taking action and being decisive. Take risks to do what is right to achieve success. Speaks up and challenges the status quo, champions own ideas and those of others. Stays up to date in areas of expertise and demonstrates use of that knowledge to successfully achieve goals and objectives. Develops credibility with teammates through in-depth knowledge of issues, problems and potential solutions. Stays up to date with new and evolving trends. Makes sound decisions based upon knowledge and expertise. 8+ years' experience in the medical device, healthcare or similar regulated industry. Previous experience in a supervisory, manager role or the ability to demonstrate mentoring/coaching of team members in areas of quality. Bachelors in STEM or a similar related degree. Experience in leading internal audits and/or supplier audits. Experience in facilitating external audits with certifying organisations and/or regulators. Subject Matter Expertise of regulations and core processes relating to Quality Systems (for example, CAPA, Nonconforming product/process, Supplier Management, Supply Chain Operations, Regulatory Approvals, Auditing, Post Market, Complaints, Field actions, Customer Feedback / Satisfaction). High level of communication skills both verbal and written and ability to interpret regulations and quality procedures. Experience leading projects, continuous improvement initiatives, Value Improvements (VIP) using Project Management and/or Lean/6-Sigma principles. Experience in leading a business through nonconforming events and implementation of corrective and preventive actions to mitigate and address risk. Well-developed people skills and ability to actively engage with stakeholders. Strong problem solving, organisational and execution skills. High attention to detail and a collaborative approach.