About the role:
Develops, establishes and maintains quality data systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality data support for CAPA and Nonconformance management processes.
Your responsibilities will include:
- Design, develop, and maintain Excel sheets and Power BI dashboards to monitor and report on key Quality metrics.
- Analyze data from multiple quality systems to identify trends, risks, and opportunities for continuous improvement.
- Collaborate with cross-functional teams (QA, RA, Operations, Manufacturing, etc.) to define and refine data requirements for effective decision-making.
- Track quality system tasks such as CAPAs, NCRs, Product Inquiry Reports (PIRs), internal/external audits, and change controls.
- Ensure data integrity and accuracy by performing regular data validation and quality checks.
- Generate periodic reports for internal stakeholders and regulatory audits.
- Support root cause analysis and investigations by providing relevant data insights.
- Drive automation and efficiency in data collection and reporting processes.
Required qualifications:
- Bachelor’s degree in Engineering, Computer Science, Statistics, or related field.
- 2+ years of experience in data analytics or business intelligence, preferably in the medical device, pharmaceutical, food manufacturing or healthcare industry.
- Proficiency in Microsoft Power BI (DAX, Power Query, data modeling).
- High level of proficiency in the use of Excel for Data Analysis
- Solid understanding of quality systems and processes (e.g., CAPA, NCR, audits, complaints).
- Strong analytical and problem-solving skills, with the ability to interpret complex datasets.
- Excellent communication skills with the ability to present data-driven insights to both technical and non-technical stakeholders.
Preferred qualifications:
- Experience working in a regulated industry (FDA, ISO 13485, etc.)
- Knowledge of SQL or other database querying languages
- Experience with statistical analysis tools (ie: Minitab, R, Python)
- Understanding of data privacy and compliance requirements
- Lean Six Sigma or quality/process improvement certification
Compensation forhourly, non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for
salaried, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Compensation foris governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).