Key Responsibilities
- Participate in the completion of CAPA projects, ensuring compliance, and quality of records.
- Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).
- Independently investigate, gathers data, and perform preliminary analysis.
- Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.
- Identify trends potential issues, improvement initiatives.
- Ensure on-time completion of Quality Assurance engineering deliverables.
- Support team in the delivery and oversight of CAPA training program.
- Identify projects to enhance and promote effectiveness, and efficiency of the quality system and product quality.
- Support Operations to make Quality / Compliance decisions on product during processing, manufacturing, testing, monitoring and packaging.
- Provide support and subject matter expertise during audits and inspections.
Qualification And Experience
- Minimum Level 7 NFQ qualification or equivalent in a relevant discipline.
- Min of 4 years experience in Engineering/Manufacturing/Scientific environment.
- Previous CAPA and/or quality assurance/engineering experience.
- Ability to demonstrated use of quality tools/methodologies.
- Prior medical device experience preferred.
- Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
- Good communication and interpersonal skills.
- Previous project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- Advanced computer skills, including statistical/data analysis and report writing Skills
