Senior Quality Engineer

Posted Yesterday
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Palm Beach Gardens, FL, USA
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Lead quality assurance for on-site medical device manufacturing, supporting New Product Introduction and continuous improvement. Ensure GMP/ISO compliance, design and audit quality systems, approve manufacturing documentation, develop SOPs and validation strategies, execute test method validations, implement risk management and statistical process controls, and monitor process performance metrics.
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:

DePuy Synthes is recruiting for a Senior Quality Engineer, located in Palm Beach Gardens, 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.

DePuy Synthes provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to healthcare systems worldwide. For more information, visit www.depuysynthes.com.

As a Senior Quality Engineer, you will support the rapidly growing Velys Enabling Tech Operation, providing overall quality assurance leadership of on-site manufacturing areas.  This position is focused on the support of New Product Introduction and Continuous Improvement projects at the Palm Beach Gardens site.

If you have a passion for innovative products and want to work on exciting projects in a multidisciplinary environment that helps people live better, this is the job you’ve been searching for!    

 

Key Responsibilities:
  • Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP) and international organization for standardization (ISO).
  • Collaborate with cross-functional team to ensure smooth transfer of new products into manufacturing.
  • Provide product team support for quality system design, audit, and compliance assessments.

·       Audit and approve manufacturing, quality, engineering, and validation documents for conformance to business practices and departmental procedures.

  • Develop standard operating procedures, specifications, and provide technical transfer and validation support.
  • Provide data and documentation in support of the development of validation strategies. 

·       Provide sampling plans and approve inspection methods for evaluation and testing of components and products.

  • Create and execute test method validations for test fixtures and gages.
  • Implement, monitor, and report out on process performance metrics to ensure effectiveness of quality systems to identify, correct, and prevent defects.
Qualifications

Education:

  • B.S. degree in Engineering or related technical field is required.  
Experience and Skills:

Required:

  • 3+ years of related experience (or equivalent with advanced degree) is required.
  • Experience working in regulated industries.
  • 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.
  • Technical training and experience using Statistics, Lean, and Six Sigma Methodologies including Measurement System Analysis, SPC, DOEs, Reliability, etc.
  • Demonstrated project management and project leadership abilities.
  • Strong communication, teamwork, problem solving, and decision-making skills.
Preferred:
  • 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.
Other:
  • This position will require less than 10% travel.

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-Hybrid



Required Skills:



Preferred Skills:

Skills Required

  • B.S. degree in Engineering or related technical field
  • 3+ years of related experience (or equivalent with advanced degree)
  • Experience working in regulated industries
  • Relevant experience working in manufacturing/operations
  • In-depth knowledge of product/process risk management (MDSAP, MDD, MDR, FDA and ISO standards)
  • Proven track record of implementing appropriate risk mitigation
  • Technical training and experience using Statistics, Lean, and Six Sigma methodologies including Measurement System Analysis, SPC, DOE, Reliability
  • Demonstrated project management and project leadership abilities
  • Strong communication, teamwork, problem solving, and decision-making skills
  • Strong knowledge of statistical software packages (e.g., for graphing and analysis)
  • Understanding of the New Product Introduction (NPI) process and Process Validation expertise

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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