Boston Scientific
Quality Compliance Manager, Cardiology
Boston Scientific, Arden Hills, Minnesota, United States
Overview
Location:
US-MN-Arden Hills Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance Boston Scientific offers opportunities to grow by working in diverse, high-performing teams tackling important health challenges. You’ll have access to the latest tools, information, and training to advance your skills and career, with support for your progression and ambitions.
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 leading key compliance and training teams.
Your responsibilities
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
Requisition ID: 613910
Minimum Salary: $99,100
Maximum Salary: $188,300
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific will vary based on actual location of the position and other pertinent factors. Compensation will be commensurate with experience, education, and certifications. It is not typical for an individual to be hired near the bottom or top of the listed salary range.
Compensation for non-exempt (hourly), non-sales roles may include variable compensation such as overtime, shift differential, and annual bonus targets (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may include variable compensation such as annual bonuses 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 is committed to solving health challenges with a diverse and inclusive workplace. We provide equal opportunity and strive to reflect the communities we serve.
Boston Scientific Corporation is an equal opportunity employer. Recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made without regard to race, religion, color, national origin, citizenship status, sex, sexual orientation, gender identity or expression, veteran status, age, or disability, among other protected classes.
Some US-based positions may require proof of COVID-19 vaccination. The company will inform candidates during the interview process if vaccination is a requirement. The company continues to evaluate its policies and will comply with applicable laws and healthcare credentialing requirements. Prohibited substance testing may be required for safety-sensitive roles to ensure workplace safety.
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Location:
US-MN-Arden Hills Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance Boston Scientific offers opportunities to grow by working in diverse, high-performing teams tackling important health challenges. You’ll have access to the latest tools, information, and training to advance your skills and career, with support for your progression and ambitions.
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 leading key compliance and training teams.
Your responsibilities
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
Requisition ID: 613910
Minimum Salary: $99,100
Maximum Salary: $188,300
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific will vary based on actual location of the position and other pertinent factors. Compensation will be commensurate with experience, education, and certifications. It is not typical for an individual to be hired near the bottom or top of the listed salary range.
Compensation for non-exempt (hourly), non-sales roles may include variable compensation such as overtime, shift differential, and annual bonus targets (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may include variable compensation such as annual bonuses 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 is committed to solving health challenges with a diverse and inclusive workplace. We provide equal opportunity and strive to reflect the communities we serve.
Boston Scientific Corporation is an equal opportunity employer. Recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made without regard to race, religion, color, national origin, citizenship status, sex, sexual orientation, gender identity or expression, veteran status, age, or disability, among other protected classes.
Some US-based positions may require proof of COVID-19 vaccination. The company will inform candidates during the interview process if vaccination is a requirement. The company continues to evaluate its policies and will comply with applicable laws and healthcare credentialing requirements. Prohibited substance testing may be required for safety-sensitive roles to ensure workplace safety.
#J-18808-Ljbffr