Manager, Sterility Assurance

Manager, Sterility Assurance

Lead Sterility Assurance team to ensure compliance to ANSI/AAMI/ISO, FDA Quality System Regulation, ISO13485 related to medical device sterilization, microbiology and related product and manufacturing process controls.

• Manage the Sterility Assurance team to drive compliance to applicable FDA, ISO, ANSI/AAMI and Company requirements, including all safety, quality and operational documentation and practices.
• Provide knowledge and recommendations for processing products through gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma and both moist and dry heat forms of sterilization.
• Merge cGLP, CGMP, ANSI, AAMI, ISO, FDA, EPA and USP guidelines with actual bioburden, cytotoxicity and bacterial endotoxin test results to create knowledge that is capable of innovatively advancing quality improvement initiatives that address sterility concerns on orthopedic devices.
• Review/approve product and sterilization process change control documentation and specifications.
• Actively participate in cross-functional projects that develop and improve manufacturing processes for existing and new products.
• Benchmark and evaluate customer needs.
• Manage all sterilization validations, dose audits, customer inquiries specific to sterilization and cleaning, residual evaluations, and all other processes that have the potential of negatively impacting product quality from a sterility, cleanliness or biocompatibility view point.
• Provide vision, guidance and effective communication to all team members to ensure the team's understanding and achievement of Quality, Cost, Delivery, Safety and Talent objectives.
• Manage, coach, mentor, and develop the performance of team to drive and support a high performance work culture; includes writing and delivering performance appraisals, administering disciplinary action, providing positive recognition, liaising with Human Resources to ensure consistency in administration and compliance with Company policies, focusing on the development of high-potential employees and crafting succession plans, and establishing a collaborative environment that encourages and supports employee engagement.
• Develop and manage the departmental budget.
• Ensure employees are provided with proper training and development.
• Build a strong, talented team through active participation in employee selection and recruiting activities.
• Ensure provision of a clean, safe and environmentally compliant work environment.
• Develop and foster relationships with peers, other internal customers (Mfg., QA, IT, Finance, etc.) and external customers/vendors to gain perspective and identify opportunities for improvement and efficiency when dealing with business issues.

Qualifications/Work Experience

QUALIFICATIONS:

7 years of medical device or pharmaceutical microbiological or biological testing, or research and development experience that includes product sterilization

2 years of direct management over microbiologists or other technicians in the field of life science

Prefer experience in a medical device manufacturing environment

Applied knowledge of microbiological and sterilization concepts, practices, and procedures

These include gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, and both moist and dry heat forms of sterilization

Demonstrated knowledge of endotoxin and bioburden testing

Advocate for product excellence and quality

Demonstrated ability to multi-task

Ability to cross-reference and keep current on relevant ANSI, AAMI, ISO, USP, EPA, EU and related guidelines

Demonstrated ability to work on cross-functional teams

Prefer experience leading project teams and using project management tools

Demonstrated problem-solving skills, and ability to troubleshoot and organize priorities

Ability to learn quickly and respond to the urgent needs of the team, ensuring all deadlines are met

Prefer knowledge in analytical chemistry and cleaning validations

Demonstrated leadership, interpersonal and influence skills, with the proven ability to teach and coach individuals from diverse backgrounds with varying communication and technical skills

Demonstrated ability to implement performance measures, drive team effectiveness and productivity, while maintaining high levels of employee engagement and morale

Demonstrated presentation and communication skills (written and verbal)

Individual will present at all levels of the company

Demonstrated proficiency in MS software, including Word, Excel, PowerPoint, Outlook, MS Project and Visio

Education and/or Special Training

EDUCATION:

Bachelor of Science degree in Biology, Microbiology or a closely related life science. Prefer Master's Degree.

Percent Travel Required