Quality Compliance Analyst

Johnson & JohnsonBrunswick, OH
$65,000 - $117,000Hybrid

About The Position

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. This role is responsible for executing and supporting regional operations in the areas of Document Management, Quality, Compliance, and SOX Reporting and for providing superior advisory and analytical support to internal and external customers enabling the compliant execution of critical customer focused operations.

Requirements

  • Bachelor’s degree in Quality, Engineering, Supply Chain, Life Sciences, Business, or a related field.
  • 2 to 4 years work experience in relevant Quality, Compliance, or Supply Chain position within a regulated, fast-paced business environment.
  • Work experience in Quality, Compliance, Document Management/Control, Technical Writing, or Supply Chain.
  • Ability to analyze basic data and identify trends to support continuous improvement.
  • Proficiency with standard office and data tools (e.g., Microsoft Office).
  • Demonstrated time management skills with consistent track record to handle multiple competing priorities/deadlines, ability to act with a sense of urgency, and deliver expected/exceeding results.
  • English (required).

Nice To Haves

  • Coursework or concentration in Quality Management, Regulatory Affairs, or Operations.
  • Experience in a medical device, pharmaceutical, or other regulated industry.
  • Exposure to audits, CAPA, change management, or supplier quality activities.
  • Familiarity with Lean, Six Sigma, or continuous improvement methodologies.
  • Experience supporting global or multi-site operations.
  • Ability to work effectively in cross-functional teams.
  • Effective written and verbal communication skills.
  • Strong attention to detail and ability to manage documentation accurately.
  • Quality-related certifications (e.g., ASQ) preferred.

Responsibilities

  • Support and continually work within the parameters established by a risk-based Quality Management System framework.
  • Serve as the Customer Service (CS) Subject Matter Expert (SME) regarding SOX financial reporting, Quality and Compliance.
  • Benchmark internally and externally, regionally and globally, to gather, share, and implement standard methodologies accordingly.
  • Assist CS Senior Leaders with development and implementation of organizational and strategic plans designed to improve efficiency of department processes, using technology and other platforms to standardize, leverage and/or eliminate manual interactions wherever possible.
  • Lead and manage projects related to broader Supply Chain initiatives.
  • Support change management strategies by applying change management principles and tools.
  • Support the development and maintenance of internal resources to provide accurate SOX financial, Quality and Compliance information.
  • Provide CS Quality & Compliance expertise on applicable projects.
  • Lead and/or support key departmental/cross-functional/cross-sector projects, as assigned, by developing and utilizing in-depth knowledge of business processes and systems, as well as project management skills.
  • Use continuous improvement tools and methodology, including Process Excellence, LEAN, and project management, to identify, evaluate, challenge, develop solutions, and optimize business processes that drive measurable improvement.
  • Regularly communicate in all directions to keep associates, peers, and Management informed of project status, process changes, and opportunities.
  • Drives / supports regional and global CS projects for the US region using FPX methodology, tools and best practices.
  • Conducts lessons learned post-implementation and identifies opportunities to continuously improve.
  • Support documentation management, Quality, and Job Function Curriculum (JFC).
  • Support with managing departmental/Regional Change Control documentation and deliverables to ensure the on-time completion.
  • Support with the on-time completion of Annual Training Record Review (ATRR) and lead on-time completion of controlled document periodic review.
  • Support with Key Performance Indicators for On-Time Periodic Review.
  • Support with development, implementation, and evaluation of metrics with meaningful insights for customer service in the areas of Document Management.
  • Complete required compliance/assigned training by required due date.
  • All duties as assigned by manager and/or supervisor.

Benefits

  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
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