Ensuring quality standards and procedures are upheld in all site and operational processes for Abbott's Neuromodulation Division, which includes implantable devices for chronic pain and movement disorders
Requirements
- Experience in the medical device industry or other regulated industry
- Six Sigma training/certifications
- Analytical Skills: Proficiency in data analysis and interpretation to identify patterns, trends, and opportunities for process optimization
- Regulatory Knowledge: Familiarity with industry regulations and standards relevant to the organization's operations, such as ISO, FDA, or other regulatory bodies and standards affecting IVDs, IVDR, and biologics, etc
- Technical Proficiency: Comfortable using quality management software, data analysis tools, and other relevant technologies to support quality assurance efforts
- Bachelor's Degree or an equivalent combination of education and work experience
- Minimum 5 years of industry related experience
Responsibilities
- Quality Assurance Oversight: Oversee the implementation and maintenance of quality assurance processes and procedures throughout all site and operational activities
- Team Leadership: Lead a team of quality assurance specialists, providing guidance, training, and support to ensure their effectiveness in executing quality control measures
- Process Improvement: Identify areas for process improvement to enhance efficiency, reduce errors, and optimize resource utilization
- Quality Management and Monitoring: Develop and implement systems for monitoring the quality of products, services, and operational processes, including regular audits and inspections
- Compliance Management: Ensure compliance with industry regulations, company policies, and quality standards, and implement corrective actions as needed
- Mentorship and Coaching: Assist employees in the creation of development plans and work with employees to meet their development needs
- Data Analysis and Documentation: Analyze quality data and performance metrics to identify trends, root causes of issues, and opportunities for improvement
Other
- Bachelor's Degree or an equivalent combination of education and work experience
- Minimum 5 years of industry related experience
- 3+ years Supervisor Experience (preferred)
- Excellent verbal and written communication skills (preferred)
- Attention to Detail: Keen attention to detail to identify discrepancies, deviations, and areas for improvement in operational processes (preferred)
- Travel: Not specified
