Senior Quality Manager, CIS

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.

With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing whatever your ambitions.

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 Bachelor's degree
• Minimum of 7 years of related experience
• Minimum of 3 years of direct or indirect management experience
• Medical device experience or regulated industry experience

Preferred Qualifications :

• Advanced degree in technical fields
• Experience leading technical teams
• Regulatory compliance experience in the areas of medical devices
• Experience with BSC complaint investigation processes highly preferred
• 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 : 590476

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.

This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.

The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most united by a deep caring for human life.

Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.

Now more than ever, we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE : BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health.

That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.

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’s status, age, mental or physical disability, genetic information or any other protected class.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

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.

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