Principal Quality Engineer, DePuy Synthes

Johnson & Johnson•Palm Beach Gardens, FL

11d•Onsite

About The Position

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. We are searching for the best talent for Principal Quality Engineer to join our DePuy Synthes Quality organization located in Palm Beach Gardens, Florida. The Principal Quality Engineer provides overall quality assurance leadership of on-site manufacturing areas engaged in the production of Johnson & Johnson products. Ensures manufacturing areas are meeting good manufacturing practices, international organization for standardization and any other applicable standards. The Principal Quality Engineer 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; applies extensive and diversified knowledge on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards.

Requirements

A minimum of 6-8 years of relevant work experience is required
A minimum of a Bachelor's degree 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.
The ability to perform "hands on" troubleshooting and problem solving is required.
Strong mentoring, coaching and leadership skills are required.
Demonstrated project management and project leadership abilities are required.
Subject Matter Expert on areas of complex technical knowledge, including statistics, six sigma, manufacturing and measurement technologies, data science, automation, etc.

Nice To Haves

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.
Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred

Responsibilities

Reviews and analyzes standard operating procedures, specifications, and provides technical transfer and validation support.
Reviews sample and scrap waste, assesses reliability and risks based on validated data, identifies root causes of problems, and reduces or eliminates sources of variation.
Interprets and provides alterations on manufacturing, quality, engineering and validation documents for conformance to business practices and departmental procedures.
Analyzes data and documentation in support of the development of validation strategies.
May acts as liaison to the regulatory affairs department to perform initial regulatory review of all engineering changes and modifications to products.
Reviews sampling plans and approves inspection methods for evaluation and testing of components and products.
Oversees reliability planning and reliability growth demonstration during new product development.
Responsible for communicating business related issues or opportunities to next management level.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.