Sr Quality Review Specialist

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 https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Business Enablement/Support

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

An internal pre-identified candidate for consideration has been identified.

However, all applications will be considered.

We are searching for the best talent for a Sr Quality Review Specialist to be in Danvers, MA.

Duties and Responsibilities


* Perform reviews of Device History Records (DHR) on the production floor for compliance to procedures, including good documentation practices (GDP), documented test results within specification, and ensuring completeness of the record


* Advising personnel on good documentation practices (GDP)


* Training and mentoring peers on the DHR review process


* Prioritizes DHR reviews based on business needs


* Support non-conformance investigations, including cause analysis and documenting findings


* Participate in Internal and External Quality Audits and support the audit program as needed

Qualifications


* Computer skills required (Microsoft Word, Excel, PDF)


* Working knowledge of SAP desired


* Medical device experience preferred or other highly regulated environment 


* Shows ability to stay organized, pays attention to important details, and effectively handles multiple tasks and priorities.


* Ability to communicate ideas and information clearly, effectively, and frequently (oral and written)


* Quality Assurance experience & knowledge of GMP desired

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 and Johnson is committed to providing an interview process that is inclusive of our applic...