Solution Delivery Specialist - Maternity - 12 months fixed term contract
Onsite Location(s): Hemel Hempstead, HRT, GB
Boston Scientific transforms lives through innovative medical solutions that improve the health of more than 30 million patients around the world each year.
We’re at the forefront of the medical device industry – leading, evolving it to address unmet and emerging needs in healthcare. Our culture powers our performance and we turn our shared vision into value with the contribution of our 36,000 colleagues around the world.
Purpose Statement
Partner with the Global Systems Project Team to support Quality Systems information needs for surveillance of product performance. Activities include identifying products affected by non-conformance issues, Hold Notices (Quality Notification System - QNS), Product Inquiry Report data generation, and Field Action data acquisition/execution. The overall objective is to support the effective management of quality system information to meet the Quality System’s requirements of Boston Scientific.
Key Responsibilities
* Implementing, maintaining, and improving the quality system at the EDC.
* Assist the Director Quality Assurance in all Quality related issues.
* Identify, diagnose, and solve existing process and system issues including the Global Complaint System, Global Labeling System, etc. Perform reporting tasks for product concerns by identifying affected UPNs, components, lots/batches for corrective actions, Hold Notices (QNS), and if necessary PIR and Field Actions.
* Work with the site and the Global Systems Project Team on the information process and improvement process around the Quality Module.
* Support the Quality team in developing and generating quality metrics reporting/tools as well as process improvements.
* Utilize the business systems enhancement process.
* Collaborate with cross-functional colleagues regarding the impacts of enhancements and process changes.
* Execute testing and training development for future roll-outs of business applications to new sites (e.g. Global Labeling System, Global Complaints System, Global CAPA system, Global Field Action Reporting System, and others).
* Deliver testing and training development for new Quality application modules and releases.
* Provide ongoing user assistance and communication for the Global Complaint System, Global Labeling System, etc. working through the local quality function management.
* Develop SOP's for reporting for PIRs and Field Actions and any process changes within their site. Lead the site implementation of any applicable QM module functionality in SAP.
* Work with Business Warehouse to develop appropriate quality reports to support the business direction of global reporting.
* Execute and monitor the facility's Quality Notifications in SAP in support of the global Field Action Process.
* Communicate with cross-functional team members at all sites to gain accurate information relating to a PIR/Field Action Reports.
* Guide and prepare site level external audits.
* Represent site Quality System with auditors.
What are we looking for in you?
* A passion for innovation and a desire to learn and develop.
* Hunger to succeed and excel.
* Growth mentality.
* Patient empathy and focus.
What we can offer to you:
* Attractive benefits package.
* Inspirational colleagues & culture.
* Fast Growing and innovative environment.
* A team-oriented company culture.
* International opportunities.
Learn more about our benefits here: EMEA
We, Boston Scientific, are an equal employment opportunity employer. We do not and will not make any personnel decisions based on a person’s age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.
Requisition ID: 598504
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. If you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
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