Boston Scientific Director Plant Quality Assurance 

United States, Minnesota, Maple Grove 

184445513

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.

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.