Site Quality Leader

DePuy Synthes is recruiting for a Site Quality Leader , to be located in Raynham, MA or Bridgewater, MA.

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/.

This person has the responsibility for driving continuous quality improvements, maintaining supply chain compliance, providing franchise support and presenting internal and external customer facing needs to Site Leaders and Business Unit partners. This includes leadership in the delivery of critical Quality Control initiatives in manufacturing, receiving and product release for Medical Devices. In addition, the Site Quality Lead of Raynham/Bridgewater will identify and facilitate the implementation of key capabilities at site that will give the Quality organization a competitive advantage. In this role, they will coordinate regional efforts related to compliance, technology investments, regulation, and resource management/optimization.

The associate partners with Site and Business Unit leaders to drive end to end Supply Chain Quality execution governance, alignment, and optimization across the network, including development and execution of strategies within multiple sites within the organization. Responsibilities include collaboration in programs that might impact localized RI from a regulatory, compliance or optimization standpoint. In addition, this role will also work closely with franchise New Product Introduction teams to ensure standard methodologies and in place for product launch stabilization (compliance and efficiency). Franchises supported by this role are: DePuy Mitek - Sports Medicine, DePuy Spine, DePuy Joints Reconstruction, Synthes, Neuravii, Cerenovus, Codman, Medos International. It is expected that you will engage the business for the inclusion and integration of additional franchise relationships.

Key Responsibilities:

• Assure execution of the quality management system at the plant and apply process excellence tools/ methodology for continuous improvement and predictability.

• Maintain plant in compliance with applicable regional and global Quality System laws regulations and standards.

• Maintains a deep understanding of quality system regulations & standards related to the medical products manufactured at the site, including but not limited to US FDA 21 CFR parts 820 & 4, ISO13485, Canadian Medical Device Regulation, European Medical Device Directive, ANVISA, TGA, Japan MHLW 169 and China GMP.

• Responsible for compliance with all corporate regulatory, human resource programs, policies and procedures, and safety/environmental systems.

• Serve as Management Representative per ISO13485 & FDA QSR and as Responsible Engineering Manager per JPAL requirements for the plant.

• Report Key Performance Indicators to top management on the performance of the quality management system and any need for improvement.

• Ensure the promotion of the awareness of the regulatory and customer requirements throughout the manufacturing site.

• Ensure that the Quality System is regularly audited/reviewed and that changes needed are implemented as required.

• Serve as a leader by recommending appropriate compliance efforts and proposing improvements to the Quality System.

• Ensure all facility associates are educated and trained in the regulatory requirements.

• Ensures the plant has the appropriate resources with the right competencies to implement the Quality System.

• 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.

• Carry outs, promotes and observes all safety, industrial hygiene rules and regulations established by the Company.

• Connect with cross-functional partners across various orthopedics businesses.

• Takes appropriate actions to build and maintain a working environment aligned with OUR CREDO.