Job Description

Recruiter: Spencer Gregory Hale

Senior Quality Manager - CIS

About This Role:
This is a unique opportunity for a strong leader to work on a high-performing and cross-functional environment leading the Electrophysiology Complaint Investigation team. This position will be based on Arden Hills and support the complaint investigation for Single Use Device and Capital Equipment including the rapidly growing Pulse Field Ablation (PFA) technology. He/She/They will interact with our design sites in Montreal, Waltham, Heredia, Arden Hills, and Manufacturing sites in Heredia and Arden Hills and with different Sourced Finished Medical Devices (SFMD)s.

The Senior Quality Complaint Investigation Site (CIS) Manager leads the Arden Hills and Coyol Complaint Investigation team responsible for in depth product analysis and product performance trending. This role is also responsible for maintaining an environment which drives continuous improvement and maintaining quality policies to ensure that products and services provided meet a high standard of customer satisfaction. The Senior Quality CIS Manager will partner closely with a variety of personnel from site, division and globally to drive continuous improvement in the effectiveness and efficiency of the Quality System. The role will champion robust product investigations and product performance analysis in support of improving the quality and patient safety of Electrophysiology products. In addition, this role will partner with customers to support effective Post Market Quality System acquisition integrations and product transfers.

 
Your Responsibilities Will Include:

• Recruit, coach and develop organizational talent
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
• Lead a team of employees in the achievement of organizational goals. Coach, direct, develop and motivate a high performing team
• Lead a team of employees responsible for in depth technical analysis and product trending and act as liaison between the CIS team and cross-functional partners (R&D, Manufacturing, Design Assurance, Supplier Quality) 
• Provides general guidance to the Product Returns supervision
• Determine appropriate staff levels and schedules; work with key partners to understand priorities and plan resource allocation accordingly
• Develop department budget, execute and monitor spend
• Keep the organization's vision and values at the forefront of decision making and action.
• Demonstrate effective change leadership
• Build strategic partnerships to further departmental, organizational objectives and drive a high performing culture
• Develop and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills
• Monitor and ensure compliance with company policies and procedures. Assures that appropriate resources (personnel, tools, etc.) are maintained to assure compliance and adherence to the BSC Quality Policy
• Lead quality team on product/system development projects of major magnitude and scope. Key Quality voice of influence on projects
• Own and drive deliverables related to quality systems, product quality, and compliance Own and drives commercial product monitoring and all related product sustainment activities
• Provide guidance, mentoring and resolution across site functions regarding quality system compliance
• Develop and implements quality strategies; seeks innovative approaches to attaining quality goals
• Ensure adherence to the Global Corporate Metrics for complaint investigations
• Directly interface with internal and external audit activities

What We're Looking For In You:

Required Qualifications:

• Minimum of a Bachelors degree in engineering or another related technical field
• Minimum of 7 years of related quality/complaint investigation experience
• Minimum of 3 years of direct management experience
• Medical device experience or regulated industry experience
• Experience leading both technical and non-technical teams
• Regulatory compliance experience in the areas of medical devices
• Experience with complaint investigation processes

Preferred Qualifications:

• Advanced degree in technical fields
• Knowledge of continuous improvement tools (Lean, Six Sigma, Robotic Process Automation) 
• Familiarity with Post Market Acquisition integrations
• Strong analytical skills
• Demonstrated leadership ability
• Passion for continuous improvement

Requisition ID: 628683  

Minimum Salary: $ 125800  

Maximum Salary: $ 239000  

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see 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.

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