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.
May 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.

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.

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.

Staff Scientist, Microbiology Quality & Sterility Assurance – Orthopedics

About this role