Staff Quality Engineer, DePuy Synthes

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Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Palm Beach Gardens, Florida, United States of America

Job Description:

We are recruiting for the best talent for Staff Quality Engineer to join our DePuy Synthes Quality organization located in Palm Beach Gardens, Florida.

The Staff Quality Engineer reports to Supply Chain Quality Director and 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. 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.

Key Responsibilities

• 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
   

Qualifications

• A Bachelor’s degree is required
• A minimum of 6-8 years of relevant work experience is required
• Experience working in regulated industries
• This position will require relevant experience working in manufacturing/operations.
• In-depth knowledge of product/process Risk Management (MDSAP, MDD, MDR, FDA and ISO standards)
• Experience and a proven track record of implementing appropriate risk mitigation
• Strong communication, teamwork, problem solving and decision-making skills
• 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 is required
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred
• Strong mentoring, coaching and leadership skills are required
• Demonstrated project management and project leadership abilities are required

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.  

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