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We are searching for the best talent for a Senior Microbiology Quality Sterility Assurance Scientist to be based in Danvers, MA.

Purpose: The Sr. MQSA Scientist is responsible for supporting the Contamination Control, Environmental, Microbiology and Sterilizations programs and practices through the implementation of the appropriate Medical Device standards. The candidate will be a subject matter expert in these areas and coordinate all activities related to them across the organization.

You will be responsible for:

• Manages a workplace in compliance with regulatory or company requirements.
• Demonstrate ability to communicate to customers and management on schedules and processing timetables to ensure timely completion.
• Integrates new technologies and test methods into routine practice. Conducts technical assessments and qualifies suppliers and other contract services. Develop innovative ideas for sterilization/ aseptic processing of products not amenable to traditional methods.
• Interfaces with Regulatory Authorities during on-site inspections and related to submissions.
• Lead MQ&SA remediation activities for regulatory findings.
• Participation as SME in internal and external audits.
• Ensure compliance of the team for a safe working environment.
• Facilitates the timely testing of Environmental Monitoring Testing, BET, Bioburden, End Product Cleaning Testing and Annual Re-Qualification process for EO sterilization processes globally as required.
• Works with R&D, manufacturing, and quality to bring new products and changes to existing products to completion as the MQSA SME.
• Works with sterilization vendors to resolve any non-conformances.
• Prepare metrics and trending reports for Sr. Management as necessary.
• Provides direction regarding Corrective and Preventative Actions that relate to MQSA related topics.
• Interprets updates to applicable international standards and guidelines and implements them into the quality system.
• Helps establish formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems.
• Coaches more junior colleagues in techniques, processes, and responsibilities.
• Develops complex subject matter expertise on R&D/Scientific Quality and assists in the review of policies that may impact organizational objectives.
• Designs systems to collect and test samples and prepares detailed observations to ensure conformity to physical and/or chemical specifications.
• Implement processes to ensure the internal organization's alignment with overall quality priorities.
• Is considered a J&J MQ&SA point of contact or a service leader within operating company supporting new and modified product/ process/packaging development and optimization.
• Support integration of new acquisitions, relative to MQSA.
• Other duties as required.

Qualifications/Requirements:

• Bachelor’s degree or equivalent required.
• 6 years of related work experience desired; Medical device experience preferred.
• Knowledge of lean, six sigma, kaizen and continuous improvement initiatives is a plus.
• Excellent verbal and written communication skills.
• Strong organizational skills; must be detailed-oriented.
• Ability to execute tasks in a timely manner independently.
• Strong knowledge of Microsoft Office Suite, and Adobe Acrobat.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

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