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. 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.

About the Role

The Process Quality Leader will supervise individual contributors and/or supervisors, ensuring effective performance management. This role evaluates existing processes, analyzes implemented changes, and recommends adjustments to workflows, schedules, or other processes. The leader will execute and coordinate studies aimed at improving product quality, efficiency, and reliability, certify internal quality audits, and provide reports on quality metrics to the Quality and management teams. Responsibilities include overseeing a team of Business Process Quality associates, training them on the latest product standards and processes, and managing operational aspects such as workflow, performance, and compliance.

Responsibilities

• Supervises individual contributors and/or supervisors, conducting effective performance management.
• Coordinates processes and assignments for supervisors and individual contributors to achieve Manufacturing Process Improvement goals.
• Coaches less experienced staff on aligning metrics and operational areas of focus to drive profitability and best-in-class service delivery.
• Advises on identifying and implementing cost-saving measures to drive profit optimization and operational efficiencies.
• Guides team on policies and procedures to ensure compliance and achievement of the organization's objectives for Manufacturing Process Improvement.
• Provides technical leadership for identifying causes of non-conformances and process failures, and implements remedial, corrective, and preventive actions to ensure compliance with Ethicon’s QSR, GMP, and ISO requirements.
• Reviews and analyzes quality trends with the manufacturing team, providing direction for setting work priorities for process enhancement.
• Provides guidance to manufacturing supervisors to ensure effective in-depth investigations are performed.
• Leads cross-functional, multilevel technical teams to identify causes of non-conformance and implement corrective/preventive actions.
• Evaluates the effectiveness of implemented corrective and preventive actions against trends.
• Leads investigations of negative trends and facilitates the implementation of process improvements in alignment with Process Engineers and Manufacturing Managers.
• Analyzes data and recommends actions for process, equipment, and system improvements.
• Writes procedures, protocols, and other documentation needed for process and system enhancement.
• Provides training and education to the manufacturing team on tools for process evaluation and enhancement (e.g., analytical troubleshooting, FMEA, statistical concepts, QSR/ISO requirements).
• Leads CAPA initiatives and recommends CAPAs based on negative trends.
• Handles, prepares data, and presents product escalation investigations (PREs), near misses, and QRB.
• Leads in-process investigations with multifunctional teams to determine root causes and recommend corrective/preventive actions.
• Handles preliminary investigations of product complaints, analysis, trends, and recommendations for corrective/preventive actions.
• Provides technical supervision to multilevel, cross-functional teams and supervises technical professionals such as college recruits, co-ops, or supervisors working on process enhancement projects.
• Complies with all environmental, safety, and occupational health policies (e.g., ISO14001 & OSHAS 18001).
• Communicates business-related issues or opportunities to the next management level.
• Ensures personal and company compliance with all federal, state, local, and company regulations, policies, and procedures.
• Performs 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 the preparation of 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
• 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.

Benefits

• Retirement plan (pension) and savings plan (401(k)) participation.
• Eligibility to participate in the Company’s long-term incentive program.
• 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.