- Ensure creation, monitoring, and correction of the quality management system according to ISO current valid version) and FDA QSR (21 CFR 820)
- Act as management representative for the QMS:To ensure QMS processes are established, implemented, and maintained.Report to senior management on the QMS performance and where improvements are needed.Ensure everyone in the organization is aware of customer requirements.
- Promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
- Regulatory compliance regarding the EU Medical Device Regulation (MDR), hereunder responsible for verification of compliance according to the EU MDR 2017/745, art. 15:Ensuring 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.Ensuring the post-market surveillance obligations are complied with in accordance with Article of the MDR.Ensuring the reporting obligations referred to in Articles 87 to 91 of the MDR are fulfilled.
- Ensure QMS standards and implementation on site
- Ensure Creation, updating and maintenance of the Quality manual.
- Ensure the control and management of all CAPA activities.
- Ensure Planning and execution of internal audits.
- Set the direction and standards of Quality at RI- site.
- Coach, train and guide peers and team members.
- Establishes KPIs to track and measure performance.
- Review & trend metrics and give feedback to the business.
- Oversee document control procedures including preparation and review of quality policies.
- Active part of the leadership team in Falmouth
- Assist & mentor teams to uphold the company compliance to local and global manufacturing Medical device standards
- Bachelor's degree in a relevant field such as quality management, chemistry, biology, or related discipline
- Master's degree of Science (MSc) in Quality Management, or Master of Quality Assurance (MQA) preferable production, or other relevant scientific field (., medical laboratory science)
- + 4 years of experience from a similar role with a licenced manufacturer, preferably within Medical Devices
- Comprehensive QM experience, preferably in medical Device.
- Internal/External audit experience, preferably a certified internal auditor.
- Experience with an international set-up.
- Motivated problem solver with the ability to work independently.
- Good communicator and team player.
- Robust and flexible mindset.
- Excellent attention to detail.
- Sound computer literacy – proficiency with Excel.
- Fluent English (spoken and written) is mandatory.
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Senior Manager, Quality Assurance Management - Falmouth, United Kingdom - CooperCompanies
Description
CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at .
In the role of Sr. Quality Manager, you will be responsible for overseeing the daily operations at our manufacturing site, including ensure regulatory compliance, implementation, and consistent performance of CSI quality requirements at the Research Instrument site.
You will ensure and monitor the effectiveness of processing operations through evaluation of quality and operational metrics and act as the representative of the Quality management system. You will take an active part in ensuing QMS processes, compliance, and communication, while reporting to management findings, performance and improvements.
You will manage quality engineers, coordinators, and goods inspector. It's not the first time you are setting the overall direction while coaching and instructing subordinates in according to procedures, policies, requirements, and medical device quality standards. You will ensure clear, concise, transparent, and constructive communication, and react on feedback and insights critical to the business.
You thrive in a dynamic environment and are comfortable juggling several complex tasks while keeping an eye on the details. You will work closely together with Quality, Regulatory, and relevant stakeholders locally and globally. You see yourself as an effective communicator, with abilities to foster teamwork and collaboration across functions, while measuring outcome and performance.
Senior Manager, Quality Assurance Management professionals in Falmouth
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Simon Matousek
Customer Support Specialist
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Gracia Yang
Fine art student