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Director, Plant QA Job

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Company :
Boston Scientific

Location :
Spencer, Indiana

Expiry Date :
Mon, 14 Jun 2021 23:59:59 GMT

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Description :
Date: May 12, 2021 Location: Spencer, IN, US, 47460 Company: Boston Scientific Additional Locations: (n/a) Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – Caring – 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 of Site Quality – Spencer About the role: The Director of Site Quality for Spencer 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, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Interfaces with the Operations, Research & Development, and Regulatory Affairs functions to accomplish quality objectives. Establishes quality systems and plans to assure design and manufacture of the highest quality products. Interacts with outside regulatory agencies as a Boston Scientific representative. This role is based 100% at the Spencer Site. We will consider internal candidates from other BSC sites if they are willing to relocate. Your responsibilities include: * The Quality Director will provide 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 will ensure that the necessary monitoring of and management of process’s including storage, retention and review, establishment of internal auditing programs, verification of all products and process’s to the established quality standards. Validation of new products/process’s or changes to existing products/process’s. * The Quality Director will build a strong and sustaining relationship with Production, Engineering, Corporate and Regulatory, external Regulatory bodies and others and will be recognized as an excellent team player within the total organization on site. * He/she will be committed to developing people and is recognized as an expert in mentoring and coaching individual and team performance while visibly demonstrating the core values of BSC in his/her everyday leadership style. * Demonstrate effective change leadership capabilities. * Ensure the BSC Quality Management System is fully implemented to comply with requirements. * Ensure 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. * Be recognized as a team player across the organization. * Direct and control the Quality budget in collaboration with others. * Communicate quality policies, strategies and procedures to the organization through written documents, presentations and discussions. * Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements) * He/she will continuously foster and drive a continuous improvement approach to Quality on Site ensuring that quality is the responsibility of everyone – not just the Quality department and that the Quality System is an integrated and integral aspect of the total running of the Site. What we’re looking for in you: Minimum Qualifications: * Bachelor’s degree plus 9-12 years of related work experience or an equivalent combination of education and work experience * 6-8 years of experience leading a team/organization of 100-200 team members * Experience in managing large -scale, complex operations/programs/projects * Excel in Collaborative Leadership * Experience in Quality Systems and methods * Experience in the Medical Device Industry * Collaborative Individual with the ability to influence Preferred Qualifications: * Advanced degree * Degree in Engineering * Familiarity and experience with BSC Quality systems and methods, products and customer needs * Lean business/VIP experience * Experience leading teams in site quality * Engineering or manufacturing background with ability to understand technical models Requisition ID: 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 is proud to be an equal opportunity and affirmative action employer. Boston Scientific maintains a drug-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. Nearest Major Market: Bloomington Indiana Job Segment: Plant, Manager, Medical, Engineer, Quality Manager, Manufacturing, Management, Healthcare, Engineering, Quality