Principal Quality Engineer, DePuy Synthes

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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.

Key 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.
  

Qualifications

• A minimum of 6-8 years of relevant work experience is required
• A minimum of a Bachelors 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.
• 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.
• Subject Matter Expert on areas of complex technical knowledge including statistics six sigma manufacturing and measurement technologies data science automation etc.
  

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals.

Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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 & 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 external applicants please contact us via .Internal employees contact AskGS to be directed to your accommodation resource.

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