Process Quality Specialist

Johnson & Johnson Innovative Medicine•San Angelo, TX

5d•Onsite

About The Position

Under the direction of the Process Quality Leader, the Process Quality Specialist provides technical support and quality expertise to help identify causes of non-conformances and process failures and support the implementation of associated remedial, corrective, and preventive actions. This role supports process performance and compliance across the business unit’s manufacturing processes in alignment with Ethicon’s QSR, GMP, and ISO requirements. The Process Quality Specialist partners closely with manufacturing, quality, engineering, and technical teams to analyze quality trends, support investigations, assist with corrective and preventative actions, and contribute to continuous improvement within a regulated manufacturing environment. This role is important to sustaining compliance, improving process performance, and supporting effective root cause analysis and resolution of quality issues.

Requirements

A University/Bachelor’s degree or equivalent experience is required.
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 or supporting investigations into non-conformances, process failures, negative trends, and quality issues.
Experience supporting 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 help 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 support 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 internal audits, external audit preparation, or inspection readiness activities.
Experience conducting or supporting audit finding investigations and timely corrective actions.
Experience working with cross-functional technical teams to improve process performance and compliance.
Experience supporting manufacturing operations, quality investigations, or compliance improvement initiatives.

Responsibilities

Review and analyze quality trends with the manufacturing team and support process enhancement priorities.
Provide guidance and support to manufacturing supervisors and process quality technicians to help ensure effective, in-depth investigations are performed.
Support cross-functional, multi-level technical teams in identifying and understanding causes of non-conformances and implementing sound corrective and preventive actions.
Evaluate implemented corrective and preventive actions against trends to help assess effectiveness.
Support investigations of negative trends and, in alignment with the Process Engineer and Manufacturing Manager, help 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 support CAPAs based on negative trends.
Handle, prepare data, and present product escalation investigations, near misses, and Quality Review Board matters.
Support 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 support 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, support manufacturing leadership 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 applicable Health, Safety, and Environmental guidelines are followed 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.