Manufacturing 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.

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FUNCTION: Supply Chain Manufacturing

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 personal. Through 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 humanity. Learn more at SUMMARY

Leads processes and assignments for the Manufacturing Process Improvement team and supports organizational objectives and business goals. Defines project terms to meet objectives and goals of the Manufacturing Process Improvement area. Directs workflow for strategic plans and serves as a primary point of contact for the team. Prepares conducts monitors and reports on audits of all quality system categories to assess compliance to good manufacturing practices equipment engineering system and international organization for standardization standards.

DUTIES & RESPONSIBILITIES

• Guides team on policies and procedures to ensure compliance and achievement of the organizations objectives for the Manufacturing Process Improvement area.
• 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 QSR GMP and ISO requirements for the entire Business Unit manufacturing process.
• Advises on identifying and implementing cost saving measures to drive profit optimization and operational efficiencies.
• 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.
• 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.

Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.

Performs other duties assigned as needed

EXPERIENCE AND EDUCATION*

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

Position requires leadership skills teamwork initiative creativity assertiveness attention to detail and effective interpersonal skills.

Required Skills:

Preferred Skills:

The anticipated pay range for this position in the primary posting location is:

The anticipated pay ranges for additional locations are:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.