Process Quality Leader

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Job Description Summary:

We are searching for the best talent for the Process Quality Leader located in Cornelia and Athens Georgia.

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 & Johnsons Credo and Leadership Imperatives in day-to-day interactions with team.

You will be responsible for:

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 organizations 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 & Johnsons 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 Ethicons 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 CAPAs based on negative trends.

Handles prepares data and present product escalation investigations (PREs) 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.

Qualifications / Requirements:

Bachelor Degree in Engineering or Science is required. Masters Degree preferred.

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.

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 and 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 please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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