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Staff Quality System Engineer - 2406189569W
Description
Biosense Webster, part of the Johnson & Johnson Family of Companies, is recruiting for a Staff Quality Systems Engineer located in El Paso, Texas; Irving Texas or Plymouth Minnesota!
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/ .
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.
You will have responsibilities in planning, implementing, execution, standardizing, coordinating, and handling quality systems including CAPA, non-conformances (NC) and product related Escalations, Field Corrective Actions for the Sterilmed business. If this sounds interesting to you apply now!
Key Responsibilities:
Establishing and maintaining policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA), European Union Medical Device Directives (MOD) and all other applicable global regulatory requirements.
Responsible for all Field Actions activities as Recall Coordinator – coordinate recall strategy plan definition with business collaborators, coordinate periodic recall meetings with the Field Corrective Action (FCA) team, maintain meeting minutes, report status to internal departments and regulatory agencies, gather documentation of all activities and follow-up recall activities to successful completion per established recall strategy.
Handling and carrying out the issues escalations process to ensure critical/ significant quality issues impacting the product in the field are presented to the Quality Review Board for decision in containment/ corrections to be implemented.
Reporting field actions metrics to appropriate review boards such as Management review, CAPA review board, periodic metrics reporting, etc.
Lead, maintain, improve and standardize Quality Systems.
Implement/modify quality systems to address changing Regulations or industry standard, providing regulatory interpretation and guidance where required.
Qualifications
Education:
Experience and Skills:
Required:
A minimum of five (5) years of proven experience in medical device manufacturing or related industry experience is required.
Prior experience in ISO 13485 and or QSR 820 FDA regulated environment is required.
Excellent interpersonal relations and communication skills.
Strong oral and written communications skills with ability to speak to broad, non‐technical audiences that are both internal and external personnel.
Skilled at preparing executive briefings and broad communications.
Preferred:
A detailed and thorough understanding of GMP/ISO regulations and validation regulations.
American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools.
Six Sigma Green/Black Belt Certified.
Other:
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.careers.jnj.com (https://jnjc.taleo.net/enterprise/www.careers.jnj.com) .
Primary Location NA-US-Texas-El Paso
Other Locations NA-US-Texas-Irving, NA-US-Minnesota-Plymouth
Organization Medical Device Business Services, Inc (6029)
Travel Yes, 10 % of the Time
Job Function Quality Systems
Req ID: 2406189569W