Operations Quality Manager

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.

Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging. WHAT WE ARE LOOKING FOR

Under the direction of the Site Quality Manager, this position is responsible for providing Quality Operations support to various departments within the site, having major impact on Quality performance and the company's ability to market products in accordance with US and international regulations. This position is also responsible for leading the site’s Quality Engineering team supporting manufacturing, product complaint management, distribution center operations, and other critical Quality functions.

Operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

YOUR ROLE

• Drive measurable quality improvements in support of operations
• Manage quality support for operations including device history record and batch release processes
• Assist various functions as a technical liaison for internal or external Quality matters
• Using Quality Engineering principles, perform statistical analysis and trending of Quality data to proactively identify opportunities and implement System improvements
• Perform regular reviews and annual reviews of employees under direct supervision. Provide performance feedback to employees, and coach as needed to foster employee improvement
• Ensure that Quality Operations employees are qualified and trained to perform their respective job functions, as required by ISO 13485:2016 and medical device regulations.
• Seek out and apply best quality assurance methods and practices in support of Quality objectives
• Develop, implement, and review procedures and work instructions to ensure compliance
• Conduct internal or external audits to assure compliance with regulatory and QMS requirements
• Perform review and approval of Technical File, Device History Records (DHRs), and other records
• Develop, review, and approve engineering change orders for compliance purposes.
• Support 3rd-party, regulatory and customer audits of the QMS, as well as requests for records
• Provide resources for the failure analysis of product, processes, and or systems for the proper identification of root causes and corrective and preventive actions
• Oversee the MRB process or assign a process owner to ensure the timely resolution of NCRs
• Manage quality, compliance, and timely closure of complaints through manufacturing investigations
• Supervise Quality Engineers and Quality Complaint Analysts that process complaints for the site
• Oversee, coordinate, and participate in elements of investigations regarding customer complaints, as required by medical device regulations (e.g., 21 CFR 820.198 and Regulation (EU) 2017/745)
• Perform Process Validation (IQ, OQ & PQ) for new product transitioning from engineering to manufacturing and production, including test system qualification.
• Review qualification, verification, and validation studies in support of product and process changes
• Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately
• Requires successful completion of assigned training
  

YOUR BACKGROUND

• Minimum of seven (7) years of experience in regulated quality systems for manufacturing environments required
• Minimum of two (2) years of direct or indirect quality supervisory experience required
• Bachelor’s degree in a STEM field (Science, Technology, Engineering & Mathematics) required. MBA or master’s degree in a STEM field preferred
• Experience in the creation and implementation of SOPs and Work Instructions
• Knowledge of FDA regulations (21 CFR Part 11, 21 CFR Part 820, etc.), EU MDD/MDR, ISO 13485:2016 and MDSAP
• Knowledge and experience with Sterilization validation and process management preferred
• Professional certification, such as ASQ CSSGB, CSSBB, CQA, CRE, and/or CQE preferred
• Proficient in the use of Microsoft Office (Word, Excel, Access, PowerPoint, & Visio) and Minitab
• Must be computer literate, including being comfortable and capable of using software programs (Word, Excel, PowerPoint) and willingness to expand and increase these competencies
• Ability to operate manual and/or electric pallet jacks