Quality Engineer II

DePuy Synthes is recruiting for a Quality Engineer II to be located in Palm Beach Gardens, Florida!

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.

The QE II provides overall quality assurance leadership of on-site manufacturing areas engaged in the production of Johnson and Johnson products, including Power Tools and VELYS robotics. They ensure manufacturing areas are meeting good manufacturing practices, international organization for standardization and any other applicable standards.

Key Responsibilities:

• The Quality Engineer II will support day-to-day manufacturing operations in the areas of nonconformance review and evaluation, process verification and validation, process risk assessments, inspection methodology and acceptance criteria for Inspection sample plans, root cause investigations, and collaborating on corrective action (CAPA).
• Provide leadership in the understanding of the QSR and ISO 13485 regulations both within Quality and to other roles and help represent Quality during internal and external audits.
• Communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing
• Implement measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, demonstrating continuous improvement
• Implementing Quality System improvements to meet compliance and overall business goals

Qualifications

Education:

• University/Bachelor's or equivalent degree is required

Experience and Skills:

Required:

• A minimum of zero to two (0-2) years of related experience
• Experience is required in the Medical Device or other regulated industry
• Strong communication, teamwork, problem solving and decision-making skills
• Experience with root cause analysis tools

Preferred:

• Experience with FDA CFR, ISO13485, MDSAP, and EU MDR
• Experience of design & test for medical safety and IEC EMC standards, such as IEC60601-1, IEC60601-1-2, IEC61000-4-6
• Experience in Test Method Validation
• Six Sigma, Lean, or ASQ Certification

Other:

• This position will require less than 10% travel
• May be required to support the 2nd shift occasionally

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.

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.