Boston Scientific Quality Compliance Manager Cardiology 

United States, Minnesota 

43977122

About the role:
The Quality Compliance Manager is responsible for developing, implementing, and maintaining compliance documentation, conducting internal audits, and driving continuous improvement initiatives. This role works cross-functionally to ensure adherence to regulatory standards and Boston Scientific quality requirements, while also leading key compliance and training teams.

Your responsibilities will include:

• Ensuring adherence to regulatory standards and internal quality requirements
• Collaborating with Compliance, Legal, and Quality teams to ensure a coordinated approach to quality and compliance
• Developing and maintaining Standard Operating Procedures (SOPs) and policies related to quality assurance and compliance
• Monitoring training operations and activities to ensure compliance with regulations and standards
• Developing and administering compliance training programs for staff
• Conducting and managing internal audits to verify compliance with relevant Boston Scientific standards
• Investigating and resolving compliance issues and complaints, including corrective and preventive actions (CAPA)
• Maintaining accurate documentation and generating reports related to compliance activities
• Driving continuous quality improvement initiatives
• Leading and managing the Quality/Compliance, Learning Management System, and Centers of Training teams

Required qualifications:

• Bachelor’s degree or equivalent industry experience
• Strong analytical skills and attention to detail
• Excellent communication and interpersonal skills

Preferred qualifications:

• 1–2 years of quality experience, preferably in the medical device or combination product field
• Experience working within an FDA-regulated environment
• Proven ability to manage compliance programs

Maximum Salary: $ 188300

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

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.