Sr. Quality Specialist - Data Control UDI

Recruiter: Spencer Gregory Hale

Sr. Quality Specialist – Data Control UDI

About the role:  

The Sr. Quality Specialist – Data Control plays an important role on the Global Quality team in ensuring Boston Scientific’s compliance with global Unique Device Identification (UDI) regulations and other quality requirements. This position leads data management activities, collaborates with our IT partners on the development and maintenance of database systems, supports the development and maintenance of quality system procedures, and engages cross-functionally with R&D/Labeling and Regulatory teams to meet requirements and ensure high-quality data across systems.  

Location(s): Arden Hills, MN; Maple Grove, MN; Marlborough, MA; Valencia, CA; Spencer IN.

Relocation assistance is not available for this position at this time

Your responsibilities will include:  

• Lead data management activities within the BSC UDI (Unique Device Identification) system


• Support development and maintenance of quality system procedures related to UDI requirements


• Serve as a key member of the UDI database product team in the regular interactions with our IT support team


• Provide guidance on UDI interpretation questions to ensure consistent compliance to regulations and internal procedures


• Coordinate with divisional and acquisition teams on data management activities


• Support compliance analysis and metrics


• Develop and deliver communication   

• Participate on or lead NCEP/CAPA teams as appropriate


• Provide project management support as needed


• Other data-related duties as necessary

What we're looking for in you:

Minimum qualifications:

• Bachelor’s degree and minimum 5 years of relevant professional experience within quality


• Familiarity with interpreting requirements and/or regulations

• Ability to analyze data against requirements


• Ability to actively engage divisional and regional resources

• Excellent communication and collaboration skills


• Strong sense of responsibility and attention to detail

• Advanced Microsoft Office Suite skills

 Preferred qualifications:  

• Understanding of Unique Device Identification (UDI) requirements for medical devices


• Understanding of the BSC UDI system and procedures


• Experience as a system product owner


• Experience with AGILE methodology


• Understanding of data management / information management

• Familiarity with other BSC data systems including SAP, PDD, MDM, Snowflake, or similar


• Project management experience


• Proven ability to influence without authority


• Experience leading NCEPs and CAPAs

Requisition ID: 623680 

Minimum Salary: $ 85000 

Maximum Salary: $ 161500 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.