Senior Quality Specialist

Boston Scientific • Arden Hills, MN

10h • $71,500 - $135,800 • Hybrid

About The Position

The Senior Quality Specialist will be a member of the high-performing EP/CRM Quality Acquisition Integration Team, leading and supporting quality integration initiatives. This individual will serve as a key contributor in determining integration strategies related to the Boston Scientific Quality System sub-process, Document Control. This role will collaborate closely with team members supporting Records Control and Data Control, as well as broader Quality System integration activities. Success in this role will require strong cross-functional collaboration across integration teams and acquired entity personnel to achieve optimal business and compliance outcomes.

Requirements

• Minimum Bachelor's degree in a related discipline and relevant 2 years experience within medical device quality or a related discipline.
• Strong understanding of medical device Quality System directives, regulations, and standards.
• Proven experience working in regulated industries, including FDA, ISO standards, EU MDR, and ISO 13485 requirements.
• Strong subject matter expertise and working knowledge of the Windchill application.
• Proven experience with additional PDM/PLM systems such as Grand Avenue, MasterControl, ETQ, or similar platforms.
• Proven experience integrating acquired entities into the Boston Scientific Quality System.
• Demonstrated ability to collaborate effectively within a team environment.
• Ability to travel as required, estimated at 10%.

Nice To Haves

• Project management knowledge and/or experience.
• Strong analytical, problem-solving, and communication skills.
• High degree of integrity, professionalism, and ability to effectively influence others.

Responsibilities

• Assess document control processes and systems at acquired entities and recommend integration strategies aligned with quality system requirements, regulatory expectations, and business priorities.
• Lead and support product integration activities by defining and executing strategies for document migration and integration into Windchill.
• Support acquired entity document control processes, as needed, to ensure business continuity and effective integration change management.
• Implement Boston Scientific document control processes at acquired entities through hybridization and progression to Boston Scientific Quality System processes and procedures.
• Support Records Control and Data Control integration efforts as needed, including leading implementation of Project Tracking Plan documentation.
• Advise integration leadership on opportunities to enhance compliance and improve Quality System processes and controls at acquired entities.
• Conduct training for acquired entity personnel on Boston Scientific document control processes and systems.
• Support change requests and change notices across the EP/CRM Quality Integration Team, as needed.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior