Senior MQSA Scientist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Sr. MQSA Scientist.

Purpose: 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.

Qualifications/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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation,  external applicants please contact us via https://www.jnj.com/contact-us/careers.  Internal employees contact AskGS to be directed to your accommodation resource.

#LIOnsite

Required Skills:

 

 

Preferred Skills:

Accelerating, Agility Jumps, Coaching, Communication, Compliance Management, Continuous Improvement, Data Savvy, Disaster Recovery (DR), Econometric Models, Issue Escalation, Problem Solving, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Researching

 

 

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

Additional Description for Pay Transparency:

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)).



This position is eligible to participate in the Company’s long-term incentive program.



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

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits