Senior MQSA Scientist

Johnson & Johnson • Cherry Hill, NJ

11d • Onsite

About The Position

The Sr. MQSA Scientist is responsible for managing the Environmental, Microbiology and Sterilizations systems 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: Facilitates annual re-certification process for EO sterilization processes globally. Works with R&D, manufacturing, and quality to bring new product and changes to existing products to completion as the sterilization SME. Works closely with engineering investigation teams to assure the timely closure of technical investigations. Responds to Request from Regulatory bodies for supplemental information or clarification of existing submittals. Works with sterilization vendors in order to resolve any non-conformances. Identify and implement improvements to the Environmental monitoring and sterilization systems. Prepare metrics and trending reports for Sr. Management monthly. Provide direction regarding Corrective and Preventative Actions that relate to the Product microbiology, sterilization and environmental monitoring. Interprets updates to applicable international standards and guidelines and implements them into the quality system. Assist management on departmental projects, as necessary. Other duties as specified.

Requirements

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

Responsibilities

• Facilitates annual re-certification process for EO sterilization processes globally.
• Works with R&D, manufacturing, and quality to bring new product and changes to existing products to completion as the sterilization SME.
• Works closely with engineering investigation teams to assure the timely closure of technical investigations.
• Responds to Request from Regulatory bodies for supplemental information or clarification of existing submittals.
• Works with sterilization vendors in order to resolve any non-conformances.
• Identify and implement improvements to the Environmental monitoring and sterilization systems.
• Prepare metrics and trending reports for Sr. Management monthly.
• Provide direction regarding Corrective and Preventative Actions that relate to the Product microbiology, sterilization and environmental monitoring.
• Interprets updates to applicable international standards and guidelines and implements them into the quality system.
• Assist management on departmental projects, as necessary.
• Other duties as specified.

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior