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Quality Assurance Specialist
2 months ago
The Quality Assurance Specialist is responsible for ensuring that processes are followed, improvements are implemented, and supports awareness, visibility, and communication on quality initiatives across the organization.
This role is to be supportive, enthusiastic, and proactive in maintaining quality methodologies, systems, processes, and practices that meet company, customer, and regulatory requirements.
This role is part of an organization committed to demonstrating diverse and inclusive behaviors.
Key Responsibilities- Coordinating quality tasks and activities associated with quality projects, complaints, field actions, document control, audits, management review, training, supplier management, and nonconformances.
- Active contributor to project teams relating to Continuous Improvement Initiatives and Value Improvement Projects (VIP) process improvements.
- Completing and compiling quality reports, metrics, key performance indicators (KPIs), and presentations.
- Understanding key quality processes associated with the role and maintaining currency to quality, regulatory requirements, company global and local policies and procedures.
- Acting as a point of contact for internal and external customers in responding to quality queries and troubleshooting issues.
- Managing issues and nonconformances in collaboration with others, supporting investigation, corrective actions, and escalating to management as required.
- Minimum 2-3 years' experience in the medical device, healthcare industry, or similar regulated environment.
- Bachelor's in science, STEM, or a related degree.
- Experience in document writing, good documentation practices, compiling presentations, and reports.
- Experience in working within a team environment, supporting projects, and a basic understanding of Continuous Improvement and Project Management initiatives is preferred but not essential.
- An understanding of Quality Management Systems (for example ISO13485 / 9001 or a similar standard).
- Experience working in a process-driven environment.
- Experience of being involved in internal/external audits or managing non-conformances is desirable but not essential.
- A sound knowledge or enthusiasm to learn electronic systems and tool applications (for example Windchill, SAP, Salesforce, Trackwise).
- Ability to organize, plan, and execute deliverables in a timely manner.
- Microsoft Office Suite intermediate (Excel, Power Point, Word).
- Reporting, data analytics, and presentation skills.
- Experience communicating with multiple stakeholders.
- Relationship Building: Establishes and maintains strong relationships internally and externally.
- Contributes to a culture of respect, diversity, and inclusion.
- Collaboration: Works effectively with others across the team to achieve goals.
- Communication: Communicates effectively one-on-one and in groups.
- Customer Focus: Identifies internal/external customer needs and ensures the effective delivery of high-quality solutions, products, and services.
- Planning: Implements initiatives and plans that align with individual or team objectives.
- Execution: Pursues all assignments and projects until completion.
- Analysis: Analyzes problems and opportunities and their impact on outcomes.
