Quality Engineer, DePuy Synthes

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Job Description:

We are searching for the best talent for Quality Engineer to join our DePuy Synthes Quality organization located in Palm Beach Gardens FL.

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies orthopedic and interventional solutions we aspire to improve and enhance medical care for people worldwide. Together we are working to shape the future of health through differentiated products and services.

Our rapidly growing Velys Enabling Tech Operation is in need of a Quality Engineer who provides overall quality assurance leadership of on-site manufacturing areas. Ensures manufacturing areas are meeting good manufacturing practices international organization for standardization and any other applicable standards. This position is focused on the support of New Product Introduction and Value Improvement projects implementation to the PBG Site.

Key Responsibilities

• Provides comprehensive quality support for daily manufacturing activity.
• Manages the initiation containment investigation disposition and closure of Non-Conformances in the PBG and WPB MAKE Sites.
• Performs and/or supports CAPA records including risk assessment root cause investigation corrective and preventive actions and effectiveness monitoring.
• Utilizes industry and process excellence standards on a moderately complex level in daily quality operations including good manufacturing practices (GMP) equipment engineering system (EES) and international organization for standardization (ISO).
• Addresses or escalates product and process complaints.
• Evaluates contract manufacturer performance metrics and supports management reviews.
• Conducts audits of all quality system categories to assess compliance to process excellence standards.
• Implements comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify bracket correct and prevent defects demonstrating continuous improvement to man.
• Facilitates technical issues for manufacturing processes that are to be transferred to satellite facilities.
  

Qualifications

Education:

• A minimum of a Bachelors degree is required. Degrees in Engineering Life Science or related field is preferred.
  

Experience and Skills:

Required:

• A minimum of 1-2 years of relevant work experience or internships.
• 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
  

Preferred:

• Advanced knowledge of Six Sigma methodologies.
• Understanding of the NPI (New Product Introduction) process
  

Other:

• This position will require less than 10% travel
  

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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