Site Quality Lead

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https://www.jnj.com

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https://www.jnj.com/

J&J MedTech (GATT Technologies B.V.) is recruiting for a Site Quality Lead reporting to the Supply Chain Quality Director Biosurgery and to be based in Nijmegen, Netherlands.

JOB SUMMARY

Under general direction and in accordance with all applicable laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:

• Assure establishment, implementation, and execution of the quality system at the GATT Technologies B.V., Nijmegen plant and utilize process excellence tools/ methodology for continuous improvement and predictability.
• Maintain GATT Technologies B.V., Nijmegen plant in compliance with applicable regional and global Quality System laws, regulations and standards including corporate regulatory, human resource programs, policies and procedures, and safety/environmental and occupational health systems.
• Ensure that the facilities remain continually certified to applicable licenses
• Serve as Person Responsible for Regulatory Compliance (PRRC) per EU MDR as well as Management Representative per ISO13485, FDA CFR 21 part 820 for GATT Technologies B.V.
• Maintains a thorough understanding of applicable medical device quality system regulations & related standards and promote awareness of such requirements to facility associates throughout the manufacturing site for products manufactured.
• Report to top management on the performance of the quality management system, its compliance towards requirements and opportunities for improvement. Communicate business related issues or opportunities to next management level.
• Coordinate compliance efforts within the facility
• Ensure that the Quality System is regularly audited/reviewed and that changes needed are implemented in a timely fashion.
• Support Quality Improvement Processes and all activities to achieve a World Class Manufacturing plant.
• Maintain an effective Quality Information System (Document Management, Nonconformances, etc).
• Maintain systems that assure only acceptable raw materials are used in processes and that only acceptable materials are shipped. Has the authority to stop production/shipments if quality requirements have not been met.
• Review and act as approval authority or delegated authority, retaining responsibility for all specifications, protocols, validations, fact books, and non-conformances.
• Participate in or support major plant projects, such as transfer of new product or processes.
• Ensure plants have appropriate resources with appropriate competencies to execute the Quality System.
• Scope of operation encompasses approximately 30-40 direct and extended reporting personnel. Direct subordinates typically are Quality Operations Lead, Quality Control Lead, Quality Systems Lead and Quality Engineering Lead. Ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that resources needed to do so are available and in good condition.
• Recruit, select and develop adequate human resources. Evaluate and recommend staffing requirements to insure maximum utilization of personnel to fulfill department objectives.
• Establish, and operate within an effective budget and manpower plan for the QA & QC organization.
• Approve salary increase recommendations and recommends salary increases and promotions for direct subordinates, interviews applicants for job openings, conduct performance reviews and provides guidance to subordinates.
• Enforces, promotes and observes all safety, industrial hygiene rules and regulations established by the Company.
• Takes appropriate actions to create and maintain a working environment aligned with OUR CREDO.

EXPERIENCE AND EDUCATION

• Bachelor’s degree and/or 5 to 10 years in Quality Assurance and/or Medical Device Industry.
• Five (5) years in supervisory skills, preferably QA Exempt personnel.
• Required expertise and/or education to meet requirements to be appointed as Person Responsible for Regulatory Compliance (PRRC)
• Operations in Medical Devices, Consumer or pharmaceutical environment is required; Class III medical devices is preferred.
• Experience successfully handling a multinational department, and/or a significant project is required.
• Experience driving high performing cross-functional and indirect teams that deliver results is required.
• Experience in actively participating in FDA, Notified Body or other Health Authority inspections is preferred.
• Experience in statistical tools, and process validations are preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Availability to various work schedules, which may include multiple shifts and/or extended hour daily shifts, including weekends and holidays.
• Meets all requirements to be appointed as Person Responsible for Regulatory Compliance (PRRC)
• Advanced computer and use of software applications (s).
• Database management skills.
• Leadership and management skills.
• Regulatory compliance knowledge and skills.
• Advanced Quality Systems knowledge & Product knowledge.
• Interpretation and application of QSR and ISO Standards
• Excellent communication and interpersonal relation skills.
• Statistical and analytical problem solving.
• ASQC - Certified Quality Auditor; ISO - Lead Assessor Certification; ASQC - Certified Quality Engineer; ASQC - Certified Quality Manager (preferred, but not required)
• English knowledge is required
• Dutch knowledge is preferred.

"The anticipated base pay range for this position is 80.800 EUR to 140.500 EUR on an annual basis and includes 8% holiday allowance "