Staff Quality Engineer - Johnson and Johnson

DePuy Synthes, a member of the Johnson & Johnson Family of Companies is recruiting for a Staff Quality Engineer, 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/.

The Staff Quality Engineer provides overall quality assurance leadership of on-site manufacturing areas engaged in the production of Johnson and Johnson products. Ensures manufacturing areas are meeting good manufacturing practices, international organization for standardization and any other applicable standards. Additionally, 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. The individual will be responsible for overall quality assurance leadership for quality planning, product and process transfer, system implementation, life-cycle management, market exit strategy, product discontinuation strategy, decommissioning of production equipment and processes, and end to end supply chain support.
Key Responsibilities:

• Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
• Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
• Addresses and corrects product and process complaints.
• Reports on contract manufacturer performance metrics and ensures management reviews.
• Oversees audits of all quality system categories to assess compliance to process excellence standards.
• Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline.
• Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
• Lead cross-functional teams to handle complex technical issues for manufacturing processes.
• Conduct Risk Management planning and Risk Assessment methodologies.
• Additional duties as assigned.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Diligently participate in our compliance program-related activities as denoted by your supervisor.
• Develops standard operating procedures, specifications, and provides technical transfer and validation support.
• Minimizes sample and scrap waste, assesses reliability and risks based on validated data, identifies root causes of problems, and reduces or eliminates sources of variation.
• Audits and approves manufacturing, quality, engineering and validation documents for conformance to business practices and departmental procedures.
• Provides data and documentation in support of the development of validation strategies.
• Acts as liaison to the regulatory affairs department to perform initial regulatory review of all engineering changes and modifications to products.
• Provides sampling plans and approves inspection methods for evaluation and testing of components and products.
• Provides support and expertise in reliability planning and reliability growth demonstration during new product development

Education:

• University/Bachelor's or equivalent degree is required. Other advanced degree or a degree with a focus in Engineering, Science, Computer Science, or digital area is preferred.
• Master's degree is preferred.

Experience and Skills:

Required:

• A minimum of four to six (4-6) years of related work experience.
• Experience in the regulated industry (MedTech or Pharmaceutical/Medicine).
• A minimum of two to four (2-4) years of experience in Quality Engineering.
• Experience in Quality Agreement and working with multiple Quality Management Systems.
• Experience and a proven track record of implementing appropriate risk mitigation.
• Experience in Process Mapping, Equipment Qualification and Test Method Validation, Computer System Validation, Inspection setup, Change Management, Nonconformance, CAPA.
• Strong mentoring, coaching and leadership skills are required. Strong communication, teamwork, problem solving and decision-making skills.
• In-depth knowledge of Product/Process Risk Management.
• In-depth knowledge of Market exits, product discontinuation, decommissioning of processes and equipment.
• Strong understanding of the regulatory requirements for a commercial release (MDSAP, MDD, MDR, FDA, and ISO standards).
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
• The ability to perform "hands on" troubleshooting and problem solving.
• Demonstrated project management and project leadership abilities.

Preferred:

• Over six (6) years of related work experience.
• Experience in Product/Process Transfer, System Integration/Enhancement, Electro-Mechanical Capital Equipment, Service and Repair, Inventory Management, Market exits, Product Discontinuation.
• Prior experience in Process / Manufacturing Quality is an asset.
• Prior experience with GD&T, Six Sigma, Lean Manufacturing, Continuous Improvement is an asset.

Other:

• Up to 25% of travel both domestically and internationally is required.
• We are utilizing J&J flex work schedule for 3 days in the office and 2 remote days.

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.