Job Description Summary

Responsible and accountable for managing and directing the daily aspects of the manufacturing quality, documentation, calibration, training, CAPA, quality planning and environmental monitoring systems, as applicable, at the BD Santo Domingo Site. Also, responsible for managing the processes addressing customer complaints, internal assessments, supplier quality, sterility assurance, FDA and QSRs, Medical Device Directive, Canadian Medical Device regulations, JGMPs and other regulatory compliance to corporate, federal, and international standards. Prepares and manages departmental operating budgets. Directs and develops departmental personnel. Functions as the Management Representative for the Dominican Republic site.

Job Description

Job Responsibilities

• Responsible for ensuring the maintenance of the Quality System in the growing BD DR site.
• Directing the quality of the site including inspection of raw materials, operations, technical quality, environmental monitoring, calibration, documentation, quality engineering and other as applicable.
• Participating as an active member of staff in planning, review of operations decisions of the plant.
• Ensuring compliance with regulatory requirements as applicable.
• Responsible for directing, participating, and assisting in conducting the program of internal and external audits.
• Keeping informed the quality hierarchy and plant manager of all significant situations.
• Developing and maintaining metrics dashboard with key indicators of site compliance/Quality System maturity and product performance.
• Responsible for conducting the management reviews of the Dominican Republic plant as well as follow-up actions arising out of this.
• Giving support to all activities of EHS in the DR site.
• Responsible to respond to inquiries from Division about complaints, as well as SCARs to suppliers.
• Responsible for ensuring the proper administration of the training system of the plant.
• Lead and/or participate in development of remediation plans for high-risk compliance issues.
• Lead in efforts to establish improved culture of Quality in the organization.
• Participating in other duties and projects, as assigned.

Education & Experience

• BS Degree in Science or Engineering.
• Minimum of 12 years of relevant experience in quality engineering/assurance.
• Prior leadership experience in manufacturing environment.
• Proficient in both Spanish and English languages.

Knowledge & Skills

• Knowledge of Quality Systems in regulated environments.
• Certification in a Quality System element specialty (e.g., ASQ Certified Quality Auditor, Quality Manager, Quality Engineer).
• Knowledge of complaint handling and auditing experience.
• Knowledge of internal quality audit processes.
• Prior experience managing external regulatory audits.
• ISO 13485 Certification.
• Proficient in Good Manufacturing Practices.
• Proficient in Lean and Six Sigma tools.
• Knowledge in Safety and Health Environment.
• Proficiency in technical writing and data analysis using tools like MS Excel and Power BI.

Percent of Travel Required

• Up to 25%

Primary Work Location

DOM Santo Domingo - Las Americas

Additional Locations

Work Shift