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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 Systems

Job Category:

Professional

All Job Posting Locations:

Athens, Georgia, United States of America, Cincinnati, Ohio, United States of America, Cornelia, Georgia, United States of America, Raritan, New Jersey, United States of America, San Angelo, Texas, United States of America, San Lorenzo, Puerto Rico, United States of America, Somerville, New Jersey, 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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Mexico and Brazil - Requisition Number: R-005177

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for a Staff Quality Engineer – Escalations role.

The Staff Quality Engineer is responsible for the end-to-end process related to product quality issue escalations through the decision-making framework of risk management and quality review boards to inform and support decisions to initiate field actions when appropriate.

Key Responsibilities:

• Execute and lead all associated activities related to the product risk escalation/assessment process to ensure compliance with internal and external requirements.

• Execute the overall escalation process from issue identification to presentation at the Risk Management Board (RMB) as well as the Quality Review Board (QRB), when required.

• Collect, create and review escalation documentation to ensure robustness and compliance.

• Prepare meeting content to the Risk Management Board and/or Quality Review Board to help facilitate the determinations of field actions and run the escalation meetings at the Risk Management Boards.

• Appropriately utilize risk management within the escalation process.

• Partner with Quality Operations, Compliance, Regulatory, R&D, Medical Safety, as well as other organizations who may own portions of a given product issue escalation.

• Provide periodic reports, presentations, and metrics related to product risk escalations to upper management as needed.

• Aspire to and effectively call peers to action and higher levels of accountability.

• Partner with and influence internal and external stakeholders to drive needed change and the execution of compliance related matters.

• Support data requests for audits, post market surveillance, regulatory registrations, etc, as well as provide data for periodic reports, presentations, and metrics related to product risk escalations.

• Support internal and external audits in preparation activities and serve as a subject matter expert during audits.

• Implement/modify quality systems to address changing regulations or industry standard, providing regulatory interpretation and guidance where required.

• Support the growth of other team members, so the pipeline of J&J talent remains strong well into the future.

• Other responsibilities include but are not limited to: coordinate and participate in special projects as assigned; act as backup support for product escalation Quality Engineers or other product Field Action teams.

• Participate in various projects in the spirit of continuous improvement.

• Actively participate in audit and compliance review processes.

• Demonstrate customer support and maintaining knowledge of Ethicon products and services.

• Plan, coordinate and execute the onboarding training of new associates and/or existing associates.

• Identify, lead and/or support appropriate projects towards desired business outcomes.

• Promote a work environment that challenges the status quo, leads and adapts to change, as well as creates significant positive changes in the workplace.

• Create a trusting, collaborative, and ethical work environment that positively contributes to employee engagement and retention.

• Support all needed Quality System and business related requests for data analysis, QSMR, BPDR, QRB, DRB, CAPA, NC, etc.

Qualifications

Education:

• A minimum of a Bachelor’s degree or equivalent in scientific and/or engineering discipline is required.

Experience and Skills

• Minimum of 6 years of related work experience is required.

• Experience in the medical device, pharmaceutical or other highly regulated industry preferred.

• Knowledge of ISO and/or cGMP regulations is preferred.

• Experience in an FDA regulated environment is an asset.

• An ASQ certification (CQE, CQM, CRE or CQA) is an asset.

• Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.

• Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.

• Able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Operations, Medical Affairs, Medical Safety, Compliance, Manufacturing, etc.

• Experience with internal/external audits, Risk Management, and recruiting/onboarding of prospective team members is preferred.

• Experience leading collaborative efforts within teams and implementing continuous improvement activities is preferred.

• Proven ability to successfully execute increased business responsibilities while maintaining high levels of productivity and quality of work.

• Excellent interpersonal relations, influencing and communication skills are required.

• 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.

• Ability to make solid decisions that will effectively support the business and company policies.

• Advanced skills on Microsoft Office software, including PowerPoint, is required.

• Ability to work in fast paced environment and rapidly shifting priorities with business and financial acumen.

• Highest ethical and integrity standard.

• Prioritization of work to meet deadlines.

• Able to lead and progress work forward in the face of ambiguity.

• Ability to handle and resolve conflict situations and influence key business stakeholders to deliver mutually beneficial outcomes.

• Results and performance driven – assumes personal ownership for business results and solutions; makes the customer central to all thinking.

• This position may require up to a 10% of domestic travel.

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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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