Senior Quality Engineer, DePuy Synthes

Posted Yesterday
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Palm Beach Gardens, FL, USA
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Provides quality assurance leadership for medical device manufacturing, packaging, labeling, inspection, testing, and finished-goods processes across two Florida sites. Manages nonconformances, CAPA, risk assessments, root-cause investigations, complaints, audits, quality metrics, management reviews, and continuous improvement. Ensures compliance with GMP, ISO, FDA, MDSAP, MDD, and MDR requirements while supporting manufacturing operations and value improvement initiatives.
Summary Generated by Built In

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.

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 searching for the best talent for Senior Quality Engineer to join our DePuy Synthes Quality organization at our two locations in West Palm Beach (WPB) and Palm Beach Gardens (PBG), 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 DePuy-Synthes Power Tools and Velys Enabling Technology Operation is in need of a Sr Quality Engineer who provides overall quality assurance leadership of on-site manufacturing, packaging, labelling and finished goods control processes. 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 current manufacturing operations, GMP compliance and Value Improvement projects implementation to the PBG and WPB Sites.


Key Responsibilities

  • Provides comprehensive quality support for daily manufacturing, inspection and testing 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.
  • Monitor, report and evaluate 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.
  • Provides leadership in Quality Systems compliance and applies quality control tools and techniques to ensure continuous improvements and effective implementation of CAPA.

Qualifications

Education:

  • A minimum of a bachelor’s degree is required. Degrees in Engineering, Life Science, or related field is preferred.

Experience and Skills:

Required:

  • A minimum of 3 - 5 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 change controls and risk management processes.

Other:

  • This position will require less than 10% travel
  • Full-time role and able to split time between two locations in Palm Beach County FL.

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 plans. In 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 https://www.jnj.com/contact-us/careers .Internal employees contact AskGS to be directed to your accommodation resource.


#LI-Onsite



Required Skills:



Preferred Skills:

Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control (QC), Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy

Skills Required

  • Bachelor's degree required; engineering, life science, or related field preferred
  • 3–5 years of relevant work experience or internships
  • Experience working in regulated industries
  • Relevant experience in manufacturing or operations
  • In-depth knowledge of product and process risk management, including MDSAP, MDD, MDR, FDA, and ISO standards
  • Proven track record implementing appropriate risk mitigation
  • Advanced knowledge of Six Sigma methodologies
  • Understanding of change control and risk management processes
  • Ability to split time between two locations in Palm Beach County, Florida

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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