Process Quality Specialist

ss the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://https://www.jnj.com

Job Function:
Quality
Job Sub Function:
Business Process Quality
Job Category:
Professional
All Job Posting Locations:
San Lorenzo, Puerto Rico, United States of America
Job Description:

Ethicon, a member of the Johnson & Johnson family of companies is recruiting for a Process Quality Specialist located in San Lorenzo, PR.

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://https://www.jnj.com.

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://https://www.jnj.com/medtech

Are you interested in joining a team delivering innovative supply chain capabilities through analytics support and best in class processes? Apply today!

Under the direction of the Business Unit Leader Director, provides technical leadership towards the identification of the causes for non-conformances and process' failures, and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Ethicon's QSR, GMP, and ISO requirements for the entire Business Unit manufacturing process:

• Leads investigations and rapid response teams (RRT) of the negative trends, quality/product process investigations & product complaints.

• Reviews & analyses quality trends with the manufacturing team & provides guidance for process enhancement setting work priorities, effective in-depth investigation.

• Provides guidance to manufacturing supervisors or support groups to ensure that effective in[1]depth investigations are performed.

• Manage internal audits including the internal audit observations and implementation of corrective actions.

• Analysis of data based on the trends recommends actions for process, equipment and system improvement.

• Writes procedures, protocols and any other Documentation needed for the enhancement of processes and systems.

• Provides training and education to operations team on tools for process evaluation and enhancement. (Analytical trouble shooting, FMEA, statistical concept application and QSR/ISO requirements).

• May lead a number of CAPA and should recommend CAPA's based on negative trends.

• Follow all environmental, safety and occupational health policies (i.e., ISO14001 & OSHA 18001).

• Responsible for presenting business related issues or opportunities to next management level.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Performs other duties assigned as needed.

Qualifications

Education: A minimum of a Bachelor's and/or equivalent University degree is required; Focus degree in Science, Engineering or related field is preferred.

Experience and Skills:

Required:

• Minimum of two (2) years of relevant professional work experience

• Experience in the QSR/ISO required - regulated medical device operation

• Availability to various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays.

• Bilingual (Spanish & English)

• Must have thorough knowledge in QSR, GMP, ISO and failure mode analysis techniques and analytical problem solving.

• Leadership skills, teamwork, initiative, creativity, assertiveness, attention to detail and effective interpersonal skills.

• Good negotiation skills.

• Excellent verbal and written communication and presentation skills with a focus on outstanding leadership ability.

• Must be and agile learner who can lead change and work under pressure achieving consistently high results in safety, quality, service, efficiency, and compliance through individual and team efforts.

• Will require sitting for extended periods of time, writing reports on the computer.

Preferred:

• Experience in manufacturing processes, managing investigations or process improvements

• Six Sigma or Lean trained or/and certifications

Other

• May require up to 10% domestic and/or international travel to other sites and locations

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 applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

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 applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.