Staff Quality Engineer

Johnson & Johnson MedTech; Athens (GA); On-site; USD 80,000 - 115,000; Full time

Job summary

A leading company in healthcare innovation seeks a Staff Quality Engineer in Athens, GA. The role involves leading quality engineering initiatives, improving processes, and collaborating on product lifecycle management. Ideal candidates will have a solid background in engineering, quality assurance, and project management, focusing on developing next-generation medical solutions.

Qualifications

• 4-6 years work experience in Operations, Engineering, or Quality Assurance.
• Minimum of 5 years’ experience in the Medical Device Industry.
• Experience with external auditing bodies preferred.

Responsibilities

• Construct critical Quality Engineering Supply Chain project plans and objectives.
• Coach team members on Quality Engineering non-conformance and corrective actions.
• Participate in audits and management reviews.

Skills

Statistics

Lean Methodologies

Six Sigma

Communication

Project Management

Education

Bachelor’s Degree in Engineering

Advanced Degree (preferred)

Job description

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At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com

Job Function

Supply Chain Engineering

Job Sub Function

Quality Engineering

Job Category

Scientific/Technology

All Job Posting Locations:

Athens, Georgia, United States of America, Cornelia, Georgia, United States of America

Job Description

We are searching for the best talent for a Staff Quality Engineer to be located in Cornelia, GA and Athens, GA.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech.

Purpose: The Staff Quality Engineer is a seasoned individual contributor in a scientific/technology field. Conducts core initiatives for Quality Engineering schematics, detailed layouts, and subsequent comprehensive supply chain outputs, as well as associated key performance metrics, goals, and objectives. Works collaboratively with management to drive decisions regarding Quality Engineering methods to produce leading-edge customer-tailored engineering final deliverables. The Staff Engineer devises or adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical and related projects. The staff engineer is an emerging authority in a specific technical field, exercising considerable latitude in determining technical objectives of assignments. Work is generally expected to result in the development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods.

The Staff Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business and supervise or lead technicians. 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.

You Will Be Responsible For

• Constructs critical Quality Engineering Supply Chain project plans, key milestones, and objectives, to ensure deliverables are aligned with customer’s operational needs and requirements.
• Coaches team members regarding any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
• Oversees, under general direction, capital and expense forecasts for assigned Quality Engineering projects, to ensure outputs adhere to quality, safety, and regulatory compliance requirements.
• Confers with team members on process validations for current and new Quality Engineering processes for subsequent operational integration and supply chain implementation.
• Assist in establishing ongoing training of Quality Engineering Technicians, supporting and enforcing site-specific safety and industrial hygiene requirements.
• Ensures timely escalation of any Quality Engineering issues or concerns to the next management level.
• Coaches more junior colleagues in techniques, processes, and responsibilities.
• Identified quality issues are escalated for immediate resolution and work effectively with CAPA site leaders to ensure that these are escalated to CAPA accordingly.
• Maintain regular interface with site management to achieve company goals and escalate any issue related to NCs in terms of trend, resolution or resolution regarding NC process.
• Participate as requires in Audits and Management Reviews.
• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
  
  

Qualifications/Requirements

• A minimum of a bachelor’s Degree, preferably in Engineering or related technical field; advanced degree is preferred.
• Generally, Requires 4-6 Years Work Experience.
• Minimum 5 years’ experience in Operations, Engineering and/or Quality Assurance is required.
• Background in Medical Device Industry, preferred.
• Experience leading CAPAs is an asset.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Knowledge of regulatory requirements (ISO, QSR, etc.), preferred.
• Experience with external auditing bodies, preferred.
• Process Excellence Green Belt Certification with demonstrated problem-solving and statistics skills, preferred.
• Demonstrated project management skills with strong results orientation, required.
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
• Strong communication, influencing and presentation skills, required.
• Physical Demands: Normal office environment, mental efforts.
• Work Environment: Frequent travel, Flexible to work on different shifts.
  
  

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 and 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, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Hospitals and Health Care

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