Site Quality Lead

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Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where 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 https://www.jnj.com/.

Job Summary:

The Site Quality Lead will lead the overall management and effectiveness of the quality management system and provides overall direction to the quality function.

The Site Quality Lead will plan, execute and manage the quality management system and activities including quality engineering, quality operations and laboratories, product release, quality systems, corrective and preventive action, non-conforming system, risk management processes, document control and training systems, ensuring compliance with regulatory and company requirements.

The Site Quality Lead serves as Management Representative for the plant and European Authorized Representative (EAR) for the Mentor Legal Manufacturer located outside the EU who places a medical device on the European markets.

The Site Quality Lead has the necessary independence, authority and responsibility to maintain the plant in compliance with all applicable regulatory requirements.

He/she reviews and acts as approval authority or delegated authority, retaining responsibility for all specifications, protocols, validations, fact books, and non-conformances.

Main duties and responsibilities:


* Serves as the site Management Representative as defined in the Quality System Regulation and ISO 13485.

Performs the duties of Management Representative as defined in the appropriate Quality Manual and governing procedures.


* Serves as the Authorized Representative Person Responsible for Regulatory Compliance (AR PRRC) according to EU-MDR.


* Monitoring the quality management system as part of the Quality System Management Review and Quality Audit Program to ensure compliance all applicable regulations and standards.


* Reviewing performance of the process/system for the site at planned intervals to ensure suitability, adequacy, and effectiveness of the quality management system and to identify opportunities for improvement.

Ensuring continuous process and product improvement.


* Ensuring the promotion of awareness of regulatory requirements throughout the organization.

Communicating to the organization the importance of meeting customer, statutory, and regulatory requirements.


* Defining the purpose and objectives of the quality system in the form of the quality policy and annual quality strategic plans, which are further developed into strategic goals and objectives.

Has authority and responsibility to assure the goals supporting the objectives are attain...