Operations Quality Manager

Apply now "
Date: Mar 19, 2024
Location:
Cincinnati, US
Job Type: Long-term/regular
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 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.
Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.
For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube
WHAT WE ARE LOOKING FOR
With the Cincinnati Site PRRC's appointment, this position is designated as an Interim/Deputy Person Responsible for Regulatory Compliance (iPRRC) as defined in the article 15 of EU Regulation 2017/745.
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.
YOUR ROLE
* By appointment, act as the Interim/Deputy Person Responsible for Regulatory Compliance (iPRRC) per European Medical Device Regulation.
* Provide daily leadership and direction to the Quality Operations team, ensuring that site operations comply with all applicable regulations, standards, and QMS procedures.
* 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.
YOUR BACKGROUND
* Bachelor's degree in a STEM field (Science, Technology, Engineering & Mathematics). MBA or master's degree in a STEM field preferred.
* Minimum of seven (7) years of experience in regulated quality systems for manufacturing environments.
* Minimum of two (2) years of quality managerial/supervisory experience.
* 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.
* 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.
* As Interim/Deputy PRRC, per article 15 of EU Regulation 2017/745, any employee holding this position shall possess the requisite expertise in the field of medical devices, as demonstrated by either of the following qualifications:
* A diploma, certificate, or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline; AND,
* At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
* OR, four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
* 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.
* Review and approve Technical File(s), 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).
* Ensure that Process Validation for new product transitioning from engineering to manufacturing and production, including test system qualification, is completed.
* Review qualification, verification, and validation studies in support of product and process changes.
* Support and participate in assigned projects as the Quality department's representative and/or SME.
* In the absence or unavailability of the Cincinnati Site's PRRC, act as the Interim/Deputy Person Responsible for Regulatory Compliance (iPRRC), ensuring that:
* The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released,
* The technical documentation and the EU declaration of conformity are drawn up and kept up to date,
* The post-market surveillance obligations are complied with,
* The reporting obligations related to serious incidents, field safety corrective actions, trend reporting, and analysis of vigilance data are fulfilled,
* In case of investigational devices, a statement is issued confirming that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regards to those aspects, every precaution has been taken to protect the health and safety of the subject. This statement is signed by the natural or legal person responsible for the manufacture of the investigational device.
* In the absence or unavailability of the Cincinnati Site's PRRC, the Interim/Deputy Person Responsible for Regulatory Compliance (iPRRC) has authority to make final decisions on:
* Product Release (including release of investigational devices),
* Technical Documentation and Declaration of Conformity release,
* Post-Market Surveillance,
* Reporting to authorities.
* 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.
* Carry out other duties, special assignments and projects as directed by the Site Quality Manager.
We offer continued personal development. When you join Guerbet, you :
* Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
* Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world,
* Are joining a company where we value diversity of talents coming from various horizon.
We # Innovate # Cooperate # Care #Achieve at Guerbet.
Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.
Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [email protected] or you can also call this number +19843443717

#J-18808-Ljbffr