Process Quality Leader

Johnson & Johnson • Cornelia, GA

4d • Onsite

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.

Purpose: the Process Quality Leader will Supervises individual contributors and/or Supervisors, and is accountable for conducting effective performance management. Evaluates existing processes, analyzes implemented changes, and recommends adjustments to workflows, schedules, or other processes. Executes and coordinates studies aimed at improving product quality, efficiency, and reliability. Certifies internal quality audits and provides reports on quality metrics to the other members of the Quality and management teams. Oversees a team of Business Process Quality associates and trains them on the latest product standards and processes. Responsible for managing operational aspects of their team (e.g., workflow, performance, and compliance), as well as ensuring achievement of team goals within expected standards. Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

Requirements

• Bachelor Degree in Engineering or Science is required.
• A minimum of five (5) years of experience in the QSR/ISO required-regulated medical device operation preferred.
• Experience in a quality role within the manufacturing industry preferred.
• Advanced computer skills (Microsoft Office) and use of software application (s) are required.
• Must have thorough knowledge in QSR, GMP, ISO, knowledge in applied statistics and failure mode analysis techniques.
• Proficient in the preparation of technical reports and presentations.
• Strong communication and interpersonal skills.
• Requires good negotiation skills.
• Entails heavy interaction with technical peers and manufacturing associates, in operations in the mainland.
• Position requires leadership skills, teamwork, initiative, creativity, assertiveness, attention to detail and effective interpersonal skills.
• May requires working/visiting all three shifts of the operation and working irregular hours.
• Will require sitting for extended periods of time, writing reports on the computer.

Nice To Haves

• Master’s Degree preferred.

Responsibilities

• Supervises individual contributors and/or Supervisors, and is accountable for conducting effective performance management.
• Coordinates processes and assignments for supervisors and individual contributors to achieve Manufacturing Process Improvement goals.
• Coaches less experienced staff on how to align 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 the Manufacturing Process Improvement area.
• Responsible for managing operational aspects of their team (e.g., workflow, performance, and compliance), as well as ensuring achievement of team goals within expected standards.
• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
• Under the direction of the Business Unit Manager, the PQL provides technical leadership towards the Identification of the causes for non-conformances and process’ failures, and for the implementation of the remedial, corrective and preventative actions thus assuring process performance and compliance against Ethicon’s QSR, GMP, and ISO requirements for the entire Business Unit manufacturing process.
• Reviews and analyses quality trends with the manufacturing team. Considering the quality trends provides direction in terms of setting work priorities for process enhancement.
• Provides guidance to manufacturing supervisors to ensure the effective in-depth investigations are performed.
• Provides leadership and guidance to cross functional, multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented. Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same.
• Leads investigations of the negative trends and in alignment with the Process Engineer and the Manufacturing Manager, facilities the implementation process.
• Analysis of data and based on the trends recommends actions for process, equipment and system improvement.
• Writes procedures, protocols and any other Documentation needed for the enhancement of processes and systems.
• Provides training and education to the manufacturing team on tools for process evaluation and enhancement. (Analytical trouble shooting, FMEA, statistical concept application and QSR/ISO requirements.
• May lead a number of CAPA and should recommend CAPA’s based on negative trends.
• Handles, prepares data and present product escalation investigations (PRE’s), near misses and QRB.
• Leads in-process investigations with multifunction team to determine root causes and provides recommendations for corrections on preventive actions.
• Handles preliminary investigations of product complaints, analysis, trends and recommendations or leads corrective/preventative actions.
• Provides technical supervision to multilevel, cross functional teams. Provides supervision to technical professionals such as College Recruits, Coops or Supervisors that are assigned to work on projects related to process enhancement initiatives.
• Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager