Process Quality Leader

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 .

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.

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

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 were 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 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 units manufacturing processes in alignment with Ethicons 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.

Key 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.

Qualifications:

Education:

A University/Bachelors degree or equivalent experience is required.

Experience and Skills:

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.

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 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.

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. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills: