Location
Michigan | United States
Job description
Additional Location(s): N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the Role:
The Quality Analyst I will provide support to the Arden Hills Operations teams in processing and maintaining system level product containment activities as a part of the non-conforming materials quality system sub-process for Arden Hills. This includes the collection, and analysis of complex query data from several systems (SAP, MES, SAP Business Objects) to help guide the engineering team to document system containment that can be effectively implemented and managed. The Quality Analyst I will serve as a Containment Administrator by assisting in the execution and tracking of assigned deliverables for Product Containment activities. In addition, the Quality Analyst I will assist the Quality System stewards and project managers in the execution of projects designed to improve the compliance, efficiency, and effectiveness of the BSC Quality System.
Your responsibilities will include:
- Works with the Arden Hills Operations Team partners to plan the necessary product containment activities, drafts Quality System deliverables to support containment, reports and conducts the system containment activities, which includes collaboration with operations, process flow determination, critical analysis of activities such as BOM allocation, system data analysis and transactional testing, where appropriate.
- Identifies opportunities to improve the efficiency and effectiveness of the systems and processes being used for product containment/control (process improvement/reengineering projects).
- Assess new processes and systems as the scope of Arden Hills operations is growing into adjacent medical device therapy types.
- Evaluates internal control systems used for Product Containment and recommends improvements.
- Participates in special projects as they arise, including efficiency projects, streamlining of documentation, cross-site projects, and new Containment Administrator Training.
- Collaborates with BSC Global personnel to drive improvements within SAP, MES and eCAPA.
- Supports other BSC sites with product control needs as needed.
- Performs product control verification role for Arden Hills related prior approval regulatory changes.
- Work with QA and other leaders to identify areas within the quality system in need of improvement and manage Corrective and Preventive Actions, as necessary.
- Provide data to direct Supervisor and peer management in Arden Hills and other related sites on status of product containment activities including tracking milestones, proposed completion dates, and other relevant metrics.
- When assigned a system containment to implement, this resource will ensure that the documentation supporting the containment action meet regulatory and corporate quality system standards.
- Assists in the facilitation of meetings reviewing the system containment needs and developing containment strategies with customers and fellow Containment Admins.
Required Qualifications:
- Minimum of a Bachelors Degree
- Minimum of less than one year of experience
Preferred Qualifications:
- Medical device or other regulated industry experience
- Experience working with software systems that support manufacturing activities (e.g., SAP, MES, Global Workflow, Windchill, etc.)
- Demonstrated initiative to identify and drive improvements
- Experience with process mapping
- Knowledge of CFR and ISO requirements
- Good communication skills with ability to collaborate cross functionally and be adaptable
- Ability to manage multiple concurrent deadlines and conflicting priorities
- Strong communication (oral and written), interpersonal, and problem-solving skills
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