Senior Quality Analyst Job

Additional Locations: (n/a)

Purpose and Passion Comprehensive Benefits Life-Work Integration Community Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your life's work.

Sr Quality Analyst

About the role:

Provide support for the maintenance of the Marlborough Quality System as well as assisting in site improvement efforts. This includes generation, analysis and compilation of required metrics and presentations to support Quality systems requirements. This resource will serve as a Quality System element specialist by assisting in the execution and tracking of assigned deliverables. In addition, where appropriate this resource will assist in the execution of projects designed to improve the compliance, efficiency, and effectiveness of assigned quality systems. Quality system elements in scope of potential assignment are Management Review, CAPA, Internal Auditing, External Auditing, Complaint Review Board, PIR and product aging tracking (RTSL).

Your responsibilities include:

• Drive cross-functional solutions and provide input to Global Systems and Business Processes to ensure BSC Network is as efficient as possible as it pertains to the BSC Quality System processes and especially the Design Activities sub-process. This includes becoming an expert on enterprises software in ERP, PLM, CAPA, Requirements Management among others.
• This resource to will coordinate and maintain Quality system data to assist senior leaders in making critical assessment of the health of the quality system, primarily through design activities by executing the required elements: including data collection, data base population and updating, logging and tracking of issues/action items, conducting analysis, generating reports, creating presentations, participating in core team meetings, and documentation through meeting minutes or released quality documents.
• Create summary presentations of the design activities for review by a variety of key stakeholders.
• Work with R&D and other leaders to identify areas within the quality system in need of improvement. Manage NCEPs and Corrective and Preventive Actions or process improvements, as appropriate. Support third party and internal audit preparation and execution.
• Identifies and drives Continuous Improvement activities to reduce the burden on the BSC Network resulting from certain Quality System Processes and Sub-Processes.
• Lead and facilitate elements of Quality System Integration activities, including but not limited to best practice analysis, benchmarking, harmonization and overall efficiency analysis.
• Drive cross-functional solutions and provide input to Global Systems and Business Processes to ensure BSC Network is as efficient as possible as it pertains to the BSC Quality System processes and especially the Design Activities sub-process.
• Assist in the Quality Systems portfolio management by monitoring, tracking, and providing data to management around the quality system for review in templates and presentations. Will include review of documents and other materials for purposes of data analysis.
• Provide data to project/ managers on status of project metrics for their assigned project including tracking milestones, budget attainment, and other relevant metrics.
• If assigned an improvement project work stream, this resource will ensure that project deliverables meet regulatory and corporate standards. Assist in the execution of assigned project plan and changes to business practices.
• Assists in the facilitation of meetings reviewing the analysis and discussions around action item planning.

What we’re looking for in you:

Minimum Qualifications:

• BS with minimum of 6 years of relevant experience
• Experience working with MS Excel advanced functions preferred.
• Experience with MRP and/or PDM systems.
• Experience with process mapping.
• Good communication skills with ability to collaborate cross functionally; deliver training and influence top/down and across.
• Familiar with Microsoft Office Suite (Excel, PPT, Word), and Minitab Statistical Analysis software (Minitab or equivalent).

Preferred Qualifications:

• Good analytical skills to analyze complex data sets.
• Experience with ERP and/or requirements management systems.
• Good understanding of material control processes.
• Practitioner of lean and continuous improvement. Previous experience with lean or 6-sigma tools is preferred.

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.

Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Requisition ID:475071