Staff Scientist, Microbiology Quality & Sterility Assurance, Orthopedics

Role Overview

• Responsible for end-to-end implementation of projects associated with microbiological quality and sterility assurance across the make and product development teams for Orthopedics.
• Ensure that those programs are aligned with the overall J&J Microbiological Quality & Sterility Assurance programs.
• Serve as a technical leader in the areas of microbiological quality, sterilization, and reprocessing.
• Manage a team with partners to centrally support end to end microbiological quality.
• Set the strategic and tactical direction of the team through the application of technical knowledge and expertise in microbiological quality, and sterilization processing.
• Oversee partnerships for product development, make and the deliver quality organization.
• Responsible for compliance to applicable quality regulations and standards and serves as the site subject matter expert for MQSA.

Requirements

• Bachelors or equivalent university degree in Microbiology, Biology, Engineering or related discipline is required.
• A minimum of 4-6 years of related experience in a medical device and/or pharmaceutical industry in a GMP and/or ISO regulated environment.
• Experience managing a workplace in compliance with regulatory or company requirements.
• Ability to communicate science to line management on schedules and processing timetables to ensure timely completion.
• Demonstrate strong technical knowledge in microbiological testing and requirements: including cleaning validations, sterilization validations, routine microbiological and chemical contamination control requirements and reprocessing requirements for medical devices.
• Experience integrating new technologies and test methods into routine practice.
• Conducts technical assessments, evaluates suppliers' other contract services.
• Develop innovative ideas for process improvements.
• Interface with Regulatory Authorities during on-site inspections related to submissions.
• Lead MQ&SA remediation activities from audit findings.
• Participate as SME in audits internal/external.
• Ensure compliance with the team for a safe working environment.
• Support integration of new acquisitions relative to MQSA.
• Manage processes across multiple quality management systems to support the business.
• Demonstrates strong people leader and business acumen, this position may have direct reports.
• Proficiency in the English language (oral and written) is required.
• Up to 10% domestic or international travel is required.

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time
• up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year