Stryker Senior Specialist, QMS in Carrigtwohill, Ireland
Senior Specialist, QMS
The Senior Specialist, Quality Management Systems (QMS) will be primarily responsible for the development of the quality management system in accordance with relevant regulatory requirements for medical devices. The Senior Specialist QMS will oversee and support that an effective and efficient quality management system is built and maintained. Has responsibility to ensure all necessary QS regulations are met in order to receive regulatory clearance/ certification.
Your Key Responsibilities:
Will work within the QMS team, under general supervision, with responsibility to ensure an effective and efficient quality management system is built and maintained, which includes, but not limited to the following:
Supports the Quality Management Systems compliance with the appropriate internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)
Contribute in developing optimum future state of QMS for business needs, aligned with Corporate, Divisional & SGS QMS.
Identifies improvements & inputs into the quality planning process.
Oversee and execute development and/or modification of Stryker's regional/local Quality Management Systems.
Co-ordinate Management Review and Quality Planning Review & Forums.
Assess & Quantify requirements for support of QMS to optimum structure under which the service required will be provided.
Drive GMP and GDP practices within Quality.
Identify and implement improvement opportunities to increase the efficiency and effectiveness of the Quality Management Systems.
Develop & deliver training/compliance for QMS group.
Contribute to the development, maintenance and improvements of the policies and procedures.
Implement best in class QS practices and benchmark against industry leads and regulatory requirements.
Liaise and communicate with notified bodies to manage certification changes.
Ensure QMS reflects actual activities and business needs, and supports NPD requirements
In a project environment, contribute to the development and/or modification of Stryker’s regional/local Quality Management Systems.
Proficiently take part in information systems discussions as required. Thinks about QMS from an IT perspective, including proficient contributions to SRS/URS activity.
Understands Quality Systems' & web-based interactions.
Proficiency in executing and leading projects, understands project stages.
proficient in improvement methods and processes.
Key contributor to the business process(es) and understands how IT system supports those business processes
Supports the business during audits to discuss system functionality.
Has knowledge of the system integrations
Supports the Business Process Owner/QA approver in IT change control assessment and approval on behalf of the business, with understanding of change control requirements per regulatory and internal procedural requirements.
What are we looking for?
Engineering/Science license or Engineering diploma (diplôme d'ingénieur) required
Germany / Switzerland
Bachelor degree/ Masters of Science, Engineering or equivalent/ related subject required, or
Technician degree with 4 years of experience in a quality discipline
Ireland / North America
Bachelor degree/ Masters of Science, Engineering or equivalent/ related subject required,
Minimum of 4 years in Quality/Regulatory Affairs environment with 2 years’ experience in a role exposed to Quality Management Systems.
Experience working in a regulated environment required.
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
Thorough knowledge and understanding of US and International Medical Device Regulations.
Strong knowledge of Quality Systems (e.g. CAPA, Audits, Management review, Quality Planning).
Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
Strong interpersonal skills.
Strong written and oral communication and negotiations skills.
Strong in critical thinking and "outside the box" thinking.
Highly developed problem-solving skills.
Strong analytical skills.
Demonstrated ability to successfully manage and complete projects in a matrix organization.
Demonstrated ability to work independently.
Experience in working in a compliance risk situation.
Demonstrated knowledge of U.S. Food and Drug regulations, as well as of European and international regulatory/industry guidelines/standards, and ability to interpret and apply.
High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages
Some travel may be required.
Work From Home: No
Travel Percentage: Up to 25%
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com