PROCESS QUALITY LEADER

Johnson & Johnson is seeking a highly qualified and motivated individual to join our team as a Process Quality Leader based in Raynham, MA.
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.
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For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.
Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.
Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
KEY RESPONSIBILITIES.
Prepares, conducts, monitors and reports on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards.
Under the direction of the Operations Manager/Director, the PQL provides technical leadership towards the Identification of the causes for non-conformances and process’ failures, and for the implementation of the remedial, corrective and preventative actions thus assuring process performance and compliance against Depuy QSR, GMP, and ISO requirements for the entire Business Unit manufacturing process.
Reviews and analyses quality trends with the manufacturing team.
Considering the quality trends provides direction in terms of setting work priorities for process improvement.
Provides guidance to manufacturing supervisors to ensure the effective in-depth investigations are performed.
Provides leadership and mentorship to multi functional, multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented.
Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same.
Leads investigations of the negative trends and in alignment with the Process Engineer and the Manufacturing Manager, facilitates the implementation process.
Analysis of data and based on the trends recommends actions for process, equipment and system improvement.
Writes procedures, protocols and any other Documentation needed for the improvement of processes and systems.
Provides training and education to the value stream team on tools for process evaluation and improvement.
(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.
Handles, prepares data and present product escalation investigations (PRE’s), near misses and QRB Qualifications Education.
Bachelor's Degree in Engineering or Science is required.
EXPERIENCE AND SKILLS.
Required.
A minimum of 5 years of proven experience in the QSR/ISO required-regulated medical device operation preferred.
Must have detailed knowledge in QSR, GMP, ISO, knowledge in applied statistics and failure mode analysis techniques.
Position requires leadership skills, teamwork, initiative, creativity, assertiveness, attention to detail and effective interpersonal skills.
Preferred.
Experience in a quality role within the manufacturing industry preferred.
Other.
Advanced computer skills (Microsoft Office) and use of software application (s) are required.
Proficient in the preparation of technical reports and presentations.
Strong communication and interpersonal skills.
Requires good influencing skills.
Entails heavy interaction with technical peers and manufacturing associates, in operations in the mainland.
May requires working/visiting all three shifts of the operation and working irregular hours.
Will require sitting for extended periods of time, writing reports on the computer.
Some traveling may be required 10% Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
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