Process Quality Leader

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.

About the Role

The Process Quality Leader supervises individual contributors and/or supervisors, conducting effective performance management. This role evaluates existing processes, analyzes implemented changes, and recommends adjustments to workflows, schedules, or other processes. The leader executes and coordinates studies aimed at improving product quality, efficiency, and reliability, certifies internal quality audits, and provides reports on quality metrics to the Quality and management teams. They oversee a team of Business Process Quality associates, training them on the latest product standards and processes, and manage operational aspects such as workflow, performance, and compliance.

Under the direction of the Business Unit Manager, the Process Quality Leader provides technical leadership for identifying causes of non-conformances and process failures, implementing remedial, corrective, and preventive actions to ensure compliance with Ethicon’s QSR, GMP, and ISO requirements. This role involves reviewing and analyzing quality trends with the manufacturing team, setting work priorities for process enhancement, and guiding manufacturing supervisors on effective in-depth investigations.

Responsibilities

• Supervise individual contributors and/or supervisors, conducting effective performance management.
• Coordinate processes and assignments to achieve Manufacturing Process Improvement goals.
• Coach less experienced staff on aligning metrics and operational areas to drive profitability and best-in-class service delivery.
• Advise on identifying and implementing cost-saving measures for profit optimization and operational efficiencies.
• Guide the team on policies and procedures to ensure compliance and achievement of organizational objectives.
• Provide technical leadership for identifying causes of non-conformances and implementing corrective/preventive actions.
• Review and analyze quality trends with the manufacturing team and set work priorities for process enhancement.
• Lead investigations of negative trends and facilitate the implementation of process improvements.
• Analyze data and recommend actions for process, equipment, and system improvement.
• Write procedures, protocols, and other documentation needed for process and system enhancement.
• Provide training and education on tools for process evaluation and enhancement (e.g., analytical troubleshooting, FMEA, statistical concepts, QSR/ISO requirements).
• Lead CAPA (Corrective and Preventive Actions) and recommend CAPAs based on negative trends.
• Handle, prepare data, and present product escalation investigations (PREs), near misses, and QRB (Quality Review Board) reports.
• Lead in-process investigations with multifunctional teams to determine root causes and recommend corrective/preventive actions.
• Handle preliminary investigations of product complaints, analyze trends, and recommend corrective/preventive actions.
• Provide technical supervision to multilevel, cross-functional teams.
• Supervise technical professionals such as college recruits, co-ops, or supervisors working on process enhancement initiatives.
• Ensure compliance with all environmental, safety, and occupational health policies (e.g., ISO 14001 & OHSAS 18001).
• Communicate business-related issues or opportunities to the next management level.
• Follow all company guidelines related to Health, Safety, and Environmental practices.
• Ensure personal and company compliance with all federal, state, local, and company regulations, policies, and procedures.
• Perform other duties as assigned.

Requirements

• Bachelor’s Degree in Engineering or Science is required; Master’s Degree preferred.
• A minimum of five (5) years of experience in QSR/ISO-regulated medical device operations.
• Experience in a quality role within the manufacturing industry preferred.
• Advanced computer skills (Microsoft Office) and proficiency in software applications.
• Thorough knowledge of QSR, GMP, ISO, applied statistics, and failure mode analysis techniques.
• Proficient in preparing technical reports and presentations.
• Strong communication, interpersonal, and negotiation skills.
• Leadership skills, teamwork, initiative, creativity, assertiveness, and attention to detail.
• Effective interpersonal skills and ability to work across all shifts, including irregular hours.
• Ability to sit for extended periods and write reports on the computer.

Skills

• Business Process Management (BPM)
• Business Requirements Analysis
• Business Savvy
• Compliance Management
• Developing Others
• Fact-Based Decision Making
• Inclusive Leadership
• ISO 9001
• Leadership
• Process Optimization
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Standard Operating Procedure (SOP)
• Strategic Thinking
• Tactical Thinking
• Team Management

Pay

The anticipated base pay range for this position is $94,000.00 - $151,800.00.

This position is eligible to participate in the Company’s long-term incentive program.

Benefits

Subject to the terms of their respective plans and date of hire, employees are eligible for the following benefits:

• Time Off:
  • Vacation – 120 hours per calendar year
  • Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents)
  • 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
• Retirement & Savings:
  • Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))

For additional general information on Company benefits, please visit: https://www.careers.jnj.com/employee-benefits.