Process Quality Leader
About The Position
We are searching for the best talent for a Process Quality Leader to be located in San Angelo, TX. About MedTech 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 Under the direction of the Business Unit Manager, the Process Quality Leader provides technical leadership in identifying causes of non-conformances and process failures and supporting the implementation of associated remedial, corrective, and preventive actions. This role is responsible for ensuring process performance and compliance across the business unit’s manufacturing processes in alignment with Ethicon’s QSR, GMP, and ISO requirements. About the Role The Process Quality Leader will partner closely with manufacturing, quality, engineering, and technical teams to analyze quality trends, lead investigations, drive corrective and preventive actions, and support continuous improvement within a regulated manufacturing environment. This role is critical to sustaining compliance, improving process performance, and ensuring effective root cause analysis and resolution of quality issues.
Requirements
- A University/Bachelor’s degree or equivalent experience is required.
- 4 years of experience in quality, manufacturing, engineering, operations, or a related regulated manufacturing environment is required.
- Knowledge of QSR, GMP, ISO requirements, quality systems, and regulated manufacturing processes.
- Experience identifying causes of non-conformances, process failures, negative trends, and quality issues.
- Experience supporting or leading root cause investigations, corrective actions, preventive actions, CAPAs, product escalations, near misses, or Quality Review Board activities.
- Ability to analyze quality trends and use data to assess the effectiveness of corrective and preventive actions.
- Ability to work cross-functionally with manufacturing, quality, engineering, technical teams, and area representatives.
- Strong written and verbal communication skills, including the ability to write procedures, protocols, and technical documentation.
- Strong analytical troubleshooting, problem-solving, and decision-making skills.
- Ability to provide training, guidance, and technical leadership to manufacturing teams, supervisors, and process quality technicians.
Nice To Haves
- Experience in medical device, pharmaceutical, or other highly regulated manufacturing environments.
- Experience with FMEA, statistical concepts, analytical troubleshooting, and process improvement tools.
- Experience participating in or leading internal audits, external audit preparation, or inspection readiness activities.
- Experience conducting audit finding investigations and supporting timely corrective actions.
- Experience working with cross-functional technical teams to improve process performance and compliance.
- Supervisory or leadership experience within a manufacturing environment.
Responsibilities
- Review and analyze quality trends with the manufacturing team and provide direction on process enhancement priorities.
- Provide guidance to manufacturing supervisors and process quality technicians to ensure effective, in-depth investigations are performed.
- Lead and guide cross-functional, multi-level technical teams to identify and understand causes of non-conformances and implement sound corrective and preventive actions.
- Evaluate implemented corrective and preventive actions against trends to assess effectiveness.
- Lead investigations of negative trends and, in alignment with the Process Engineer and Manufacturing Manager, facilitate implementation of corrective actions.
- Write procedures, protocols, and other documentation needed to improve processes and systems.
- Provide training and education to the manufacturing team on tools for process evaluation and improvement, including analytical troubleshooting, FMEA, statistical concept application, and QSR/ISO requirements.
- Recommend and may lead CAPAs based on negative trends.
- Handle, prepare data, and present product escalation investigations, near misses, and Quality Review Board matters.
- Lead in-process investigations with cross-functional teams to determine root causes and provide recommendations for corrective and preventive actions.
- Handle preliminary investigations of product complaints and trends and recommend or lead corrective and preventive actions.
- Participate in internal audits as a team member or lead auditor to ensure compliance with applicable quality system standards and directives in accordance with the internal audit schedule.
- Assist with preparation for and execution of quality system external audits and inspections.
- Conduct audit finding investigations and review findings with area representatives to ensure thorough understanding of compliance issues and implementation of effective, timely corrective actions.
- As required, cover for the Manufacturing Manager by providing first-level supervision in a manufacturing unit, including assigning duties, providing direction, monitoring work operations, and supporting production commitments in accordance with established policies and methods.
- Communicate business-related issues or opportunities to the next management level.
- Ensure subordinates follow all company Health, Safety, and Environmental guidelines and that required resources are available and in good condition, if applicable.
- Ensure personal and company compliance with all federal, state, local, and company regulations, policies, and procedures.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
