Director, Plant Quality Assurance

Additional Location(s) : N / A

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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.

Director, Plant Quality Assurance

About the Role :

At Boston Scientific, the Director, Plant Quality Assurance for Maple Grove leads a team of Managers, Senior Engineers, Engineers, Technicians, and other professionals to ensure full compliance to all GMP / QSR practices and standards as defined by the Food and Drug Administration, ISO, and other regulatory bodies.

In all actions, he / she / they will demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

He / she / they will interface with the Operations, Research & Development, and Regulatory Affairs functions to accomplish quality objectives.

He / she / they will establish quality systems and plans to assure design and manufacture of the highest quality products.

He / she / they will interact with outside regulatory agencies as a Boston Scientific representative.

This role is based 100% at the Maple Grove, Minnesota Site.

Your Responsibilities Include :

Providing leadership and direction to his / her team and ensure a Quality Management System exists to meet the various requirements of a medical device manufacturing facility.

Specifically, he / she / they will ensure that the necessary monitoring of and management of processes including storage, retention and review, establishment of internal auditing programs, verification of all products and processes to the established quality standards and validation of new products / processes or changes to existing products / processes.

• Building strong and sustaining relationships with internal colleagues and functions including Production, Engineering, Corporate Quality, Regulatory, divisional stakeholders, and others as needed.
• Interfacing and building effective communication and relationships with external Regulatory bodies.
• Demonstration of commitment to developing people and recognition as an expert in mentoring and coaching individual and team performance while visibly demonstrating the core values of BSC in his / her / their everyday leadership style.
• Demonstration of effective change leadership capabilities, and recognition as a team player across the organization.
• Ensuring the BSC Quality Management System is fully implemented to comply with requirements.
• Ensuring that the necessary monitoring systems are implemented, and signals responded to for production & process controls, document and records controls, design controls, material and supplier controls, post market feedback, product approvals and CAPA.
• Directing and control the Quality budget in collaboration with relevant stakeholders.
• Communication of quality policies, strategies, and procedures to the organization through written documents, presentations, and discussions.
• Monitoring and ensuring compliance with company policies and procedures (e.g., federal / country, and regulatory requirements)
• Continuously fostering and driving a continuous improvement approach to Quality and ensuring that quality is the responsibility of everyone.
• Ensuring that the Quality System is an integrated and integral aspect of the total running of the Site.

What We're Looking For :

Required Qualifications :

• Minimum of a Bachelor's degree
• Minimum of 9 years of related work experience or an equivalent combination of education and work experience
• Minimum of 5 years of people management experience
• Experience in managing large-scale, complex operations / programs / projects.
• Experience in Quality Systems and methods.
• Experience in the Medical Device Industry

Preferred Qualifications :

• Advanced degree
• Degree in Engineering
• Experience with BSC Quality systems and methods, products, and customer needs.
• Lean business / VIP experience
• Experience leading teams in a site quality setting.
• Engineering or manufacturing background with ability to understand technical models.
• Established experience in leading and solving complex problems and strategies.
• Leading culture advancement and results in technical problem solving.
• Financial experience in cost center planning and execution responsibility
• Excel in Collaborative Leadership with the ability to influence.

Requisition ID : 589534

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.

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.

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