Microbiologist II

Description

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

This position is responsible for overseeing and administering microbiology activities within the Quality System for all Cirtec cleanrooms, water systems, and sterilization. This includes specifying requirements, validation activities, establishing and maintaining controls, monitoring, and reporting. The incumbent will ensure compliance with global quality/regulatory requirements, internal requirements, and applicable standards.

Key Responsibilities:

• Develop, implement, and maintain required Regulatory compliance with all regulatory agencies, including, but not limited to, U.S. FDA, EU/ISO, Canadian, Asia-Pacific and Latin America regulations.
• Maintaining current working knowledge of FDA and global regulatory requirements, and keep Management appraised of new developments and potential impacts to our customers and the organization.
• Promotes organization to customers and fosters customer/industry relations.
• Ensures effective analysis and reporting of sterilization data. Including the development strategies to address problematic test observations and deficiencies.
• Compiles and analyzes trend data appropriate for continuous improvement and monitoring of product sterility, DI water systems, and clean rooms.
• Writes sterilization protocols, reports, and adoptions appropriate for products in compliance with the current regulations.
• As a team member, coordinates project activities for new product and product revision designs to analyze possible impacts on sterilization properties.
• Manages sterilization and environmental monitoring testing including preparing test samples, scheduling, coordinating with outside facilities, planning, and purchasing as needed.
• Authors technical documents that effectively interpret and present data and provide appropriate rationale to support conclusions regarding sterilization and environmental controls.
• Provides input to QC and Manufacturing regarding product sterility levels and provides feedback to manufacturing to ensure basic understanding of the possible causes of sterility testing / monitoring discrepancies.
• Performs internal assessments on documents and practices to ensure continuing compliance with current standards for medical device manufacturing regulations and Company SOPs as related to product sterility and controlled area environmental controls.
• Determines corrective action and performs re-assessments in response to sterilization or environmental issues and planned changes.
• Assists in developing sterilization and environmental specifications.
• Remains informed about current standards, regulations, engineering and material trends regarding sterilization and environmental control by reviewing current literature for technological application, and appropriate coursework.
• Research ideas for improvements to SOPs to improve compliance, streamline operations, and/or save cost.
• Reviews appropriate technical literature for necessary background on specific assignments.
• Travel requirement: 10%

Must Have:

• Bachelor of Science degree in Engineering or STEM field. Microbiology preferred.
• 2+ years' experience in microbiology roles in medical devices or pharmaceutical.
• Knowledge and experience with external standards: ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), especially pertaining to environmental systems, cleanrooms, DI water, and sterilization
• Ability to present in audits by customers, certification bodies, and regulatory agencies.
• Strong verbal communication. Ability to present technical information to various levels of management in a manner that is easily understood.
• Strong written communication skills including ability to write protocols and reports for engineering approval.
• Strong math & analytical skills.
• Strong working knowledge of statistics.
• Ability to apply the scientific method.
• Strong troubleshooting skills on equipment or processes.
• Strong interpersonal skills, demonstrated ability to interface on project teams as an effective team member
• Proficiency with personal computer software including word processing, spreadsheet, and statistical programs
• Must be able to read, write and speak fluent English
• Ability to effectively train others.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.