Process Quality Specialist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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We are searching for the best talent for a Process Quality Specialist to be located in San Angelo TX!

About Johnson & Johnson MedTech

Fueled by innovation at the intersection of biology and technology Johnson & Johnson MedTech is developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness.

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 units manufacturing processes in alignment with Ethicons QSR GMP and ISO requirements.

About the Role

The Process Quality Specialist partners closely with manufacturing quality engineering and technical teams to analyze quality trends support investigations assist with corrective and preventive 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.

Key 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.

Qualifications

Education

A University/Bachelors degree or equivalent experience is required.

Experience and Skills

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.

Preferred

• 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs.

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