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Job Description:

The Supervisor of MQSA is responsible for leading the site Control Contamination, Environmental, Product Microbiology, Cleaning and Sterilization systems and practices through the implementation of the appropriate Medical Device standards and harmonization with J& J practices for the site. Ensure all new product introductions are in compliance with all standard requirements and international regulations to provide the required information to Regulatory. Mentor team members to ensure development of subject matter experts in all the related areas for Sterilization & Microbiology.

Principle Duties and Responsibilities:

• Manage the Environmental Monitoring, Sterilization Validations, Cleaning assessments and Microbiology product level testing plans for the timely completion.
• Lead the timely completion of annual re-qualification process for all sterilization processes for the site.
• Collaborates with engineering teams to assure timely closure of technical investigations.
• Works with MQSA leaders, R& D, manufacturing, and quality design to bring new product and changes to existing products to completion.
• Responds to Request from Regulatory bodies for supplemental information or clarification of existing submittals.
• Identifies and implements improvements and innovative ideas with end-to-end thinking for all the areas managed.
• Prepares metrics and trending reports for Sr. Management monthly and annually.
• Provides direction regarding Corrective and Preventative Actions that relates to the product microbiology, contamination control, cleaning, sterilization, and environmental monitoring.
• Interprets updates to applicable international standards and guidelines and implements them into the quality system.
• Supports audits for manufacturing contractors or external suppliers including suppliers used for Sterilization & Microbiology.
• Support technical assessments and support qualifications of suppliers.
• Ensure cross-functional communication between team members locally and globally.
• Develop and deliver instructional training material and expertise to others internal and external to the team.
• Support department strategy to engage personnel and work succession plan with Sr. Management.
• Support planning and management of financial budgets.
• Demonstrate the ability to communicate to customers and management on schedules and processing timetables to ensure timely completion.
• Participates in internal/external audits as SME of site.
• Assists management on departmental projects, as necessary.

Job Qualifications:

• BS Degree in a Scientific or Engineering discipline required, advance degree desirable.
• Minimum of 6 years of related experience similar industry.
• Knowledge of global quality systems and regulatory requirements (21 CFR Part 11/210/211/820, ISO 13485)
• Strong knowledge of GMP’s and GLP’s.