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QMR / Quality Director France Pluvigner

2021-05-29 22:02:27
QMR / Quality Director France Pluvigner
• *Description**

+ Hillrom is a leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, and information technology solutions. Hillrom’s comprehensive product and service offerings are used by health care providers across the health care continuum in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care.

+ The QA Director is the quality functional leader for the Pluvigner site which is engaged in the design, manufacture and distribution of class I and II medical devices. This position is also the designated Quality Management Representative for all aspects of Quality System implementation. This role provides leadership to all functions within the Pluvigner site to... achieve Quality objectives, operational targets, continuous improvement, and the implementation and maintenance of an effective and compliant Quality System.

+ To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Individual must possess proficient interpersonal and communication skills to interact cross functionally. Also must be able to communicate effectively with senior management, Hillrom Legal, external resources, regulatory compliance authorities, and suppliers.
• *ESSENTIAL DUTIES AND RESPONSIBILITIES:** _– Other duties may be assigned:_

+ Serve as Quality Management Representative for the Pluvigner site, including hosting third party inspections and audits, and organizing and conducting periodic Management Reviews of the Quality System.

+ Strong partnership with Pluvigner site leader and other site and regional functional leaders.

+ Efficient escalation and effective management of critical quality topics and events.

+ Provide strategic direction and leadership to all functions and levels of the manufacturing organization to ensure operations adhere to the highest standards of compliance and product quality.

+ Direct the implementation of corrective and preventive actions, ensuring timely and robust completion of actions to enterprise targets.

+ Ensure product containment of manufacturing non-conformances, to include immediate correction activities as appropriate and determination of systemic corrective and preventive actions.

+ Review complaint trending and drive actions to improve customer experience and lower complaints.

+ Medical Device Vigilance Agent dealing with French Competent Authority ANSM concerning Hillrom SAS Medical Devices Vigilance Reporting

+ Chair the local Corrective Action Board (CAB) and represent the Pluvigner site in the Global CAPA Review Board.

+ Oversee all aspects of supplier quality for the plants, including supplier selection, qualification, and control.

+ Manage the Device History Record process including localized document control activities.

+ Lead the Design Assurance function for products designed and developed by the Pluvigner based R&D team and sustained by the Pluvigner site based engineering team.

+ Identify and mitigate gaps between Quality System requirements and all applicable regulations and corporate requirements.

+ Effectively plan and deploy resources to meet daily and strategic business needs in a timely manner while evolving the quality system to become more proactive, efficient, and effective.

+ Manage the entity Master Validation Plans, ensuring IQ, OQ, and PQ of existing, new, or modified equipment, processes or non-product software.

+ Is responsible for the ongoing relationship with the departments in charge of implementation of regulations (central and decentralized services of the State, notified or designated body).

+ Prepare and adhere to annual operating budget.
• *Qualifications**

+ Bachelor’s degree in a related medical, science or regulatory discipline required. Engineering degree / product development experience strongly preferred.

+ 10 years in the medical device industry or related GMP environment or equivalent

+ Proficient in English.

+ 5 years of experience leading direct reports.

+ Demonstrated strong proficiency with Microsoft systems (Excel, PowerPoint, Word, and Project).

+ Thorough knowledge and understanding of medical device regulations and standards, including but not limited to QSR, CMDR, Medical Device Directive,

+ ISO Quality System and other applicable industry requirements is required.

+ Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required.

+ Exceptionally strong leadership and influencing skills.

+ Must have the ability to make effective presentations to all levels of the organization.

+ The proven ability to prioritize and manage multiple projects and meet deadlines is required.

+ Must have the ability to work in both a collaborative (team) environment as well as perform independent work as required.

+ Experience building a high performance team, managing performance of team members with varying levels of skill and experience, and mentoring high potential individuals to achieve greater impact on the organization.

+ Strong appreciation of the impact of regulatory bodies on medical device product lifecycle is required.

+ Experience working with diverse cultures and employees.

+ Strong knowledge of tools and techniques for failure investigations.

+ Successful track record for identifying and implementing systemic corrective and preventive actions.

+ Knowledge of equipment and process validation requirements.

+ High degree of individual ownership and accountability.

+ Ability to manage regulatory agency inspections and respond to enforcement actions, voluntary or official, as may be needed from time to time.

+ ASQ Certifications for Auditing and/or Quality Management is preferred.

+ Occasional (<20%) overnight travel as required based on business need, including international travel. **Job:** Quality **Primary Location:** France-Pluvigner **Schedule** Full-time **Travel** No **Posting Entity** Hillrom **Req ID:** 21122906
Pluvigner France
QMR / Quality Director France Pluvigner Hill-Rom Pluvigner
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