Boston Scientific Gruppe
Sr Design Assurance Manager
Boston Scientific Gruppe, Boston, Massachusetts, us, 02298
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.About the Role:The Quality Manager is responsible for designing, planning, coordinating and executing projects oriented towards quality improvement in the site´s manufacturing processes. Provides support to Process Quality and Quality Engineering areas management. Establishes and maintains Quality Management systems that meet regulatory requirements, corporate policies, internal policies and business needs. Additionally, he/she is responsible for planning and supervising In Process Quality Engineers functions and activities.Your Responsibilities Include:Coordinate Quality Engineering and In Process Quality Engineering areas engineers’ functions and activities.Provide support to new products/process transfer projects; review risk analysis (PFMEA) for the different processes.Plan, coordinate and execute projects oriented towards in process defects prevention.Design and implement process control strategies.Facilitate and support the Quality Control supervision function through Quality Engineers and Quality Supervisors.Review and/or approval of documents, investigations, extensions or another regulatory figure within the company´s quality system, as an alternate representative of Quality Management.Provide technical support to the In Process Quality area and to other departments.Deliver training related to quality technologies.Coordinate with Corporation the implementation of projects related to the In Process Quality area.Create new procedures on In Process Quality and/or improve the existing in order to facilitate and assure regulatory compliance.Responsible for acting as Subject Expert Matter (SME) of the following chapters of the company´s quality system: 803.5 Individual Adverse Event reports, 820.70 Production and Process Controls, 820.75 Process Validation, 820.60 Identification, 820.65 Traceability, 820.72 Inspection, measuring and test equipment, 820.90 Non-conforming product, 820.80 Receiving, in-process and finished device acceptance, 820.100 CAPA, 820.198 Complaint Files.Participate as a core team member in the new products transfer process, representing Quality Assurance areas.May act as NCEP System administrator for the area: tracking and keeping NCEP investigations related to the area closed; area MRB administrator; area NCEP owner; perform continuous improvements in NCEPs for the area; coordinate with other NCEP administrators on actions executed and the impact on other areas.May provide support to the Quality Director in his/her responsibilities. Authorized to sign as the Quality Director designee or representative in his/her absence or as required.Participate in the PIR (Product Inquiry Report) process, assuring: diligent execution of activities related to the PIR, PIR assessment in the eCAPA system, PIR execution, and appropriate process communication to Corporation. May act as the Quality Director (Head of Quality) designee in PIR process activities.May provide guidance and supervision to process validation areas, software validation complaint handling, MTAC, Calibration, Microbiology, supplier, Q process development, and/or design assurance.What We’re Looking For:Licenciature degree in Industrial, Electronic, Biotechnology, Electromechanical Engineering or Field Related.At least 10 years of experience in similar position.Desired knowledge: Formal training on statistical and quality techniques, desirable ASQ Certified, Knowledge of Six Sigma, Lean, APQP or similar tools.Or an equivalent combination of education and experience.Requisition ID:
588617As 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.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, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
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Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.About the Role:The Quality Manager is responsible for designing, planning, coordinating and executing projects oriented towards quality improvement in the site´s manufacturing processes. Provides support to Process Quality and Quality Engineering areas management. Establishes and maintains Quality Management systems that meet regulatory requirements, corporate policies, internal policies and business needs. Additionally, he/she is responsible for planning and supervising In Process Quality Engineers functions and activities.Your Responsibilities Include:Coordinate Quality Engineering and In Process Quality Engineering areas engineers’ functions and activities.Provide support to new products/process transfer projects; review risk analysis (PFMEA) for the different processes.Plan, coordinate and execute projects oriented towards in process defects prevention.Design and implement process control strategies.Facilitate and support the Quality Control supervision function through Quality Engineers and Quality Supervisors.Review and/or approval of documents, investigations, extensions or another regulatory figure within the company´s quality system, as an alternate representative of Quality Management.Provide technical support to the In Process Quality area and to other departments.Deliver training related to quality technologies.Coordinate with Corporation the implementation of projects related to the In Process Quality area.Create new procedures on In Process Quality and/or improve the existing in order to facilitate and assure regulatory compliance.Responsible for acting as Subject Expert Matter (SME) of the following chapters of the company´s quality system: 803.5 Individual Adverse Event reports, 820.70 Production and Process Controls, 820.75 Process Validation, 820.60 Identification, 820.65 Traceability, 820.72 Inspection, measuring and test equipment, 820.90 Non-conforming product, 820.80 Receiving, in-process and finished device acceptance, 820.100 CAPA, 820.198 Complaint Files.Participate as a core team member in the new products transfer process, representing Quality Assurance areas.May act as NCEP System administrator for the area: tracking and keeping NCEP investigations related to the area closed; area MRB administrator; area NCEP owner; perform continuous improvements in NCEPs for the area; coordinate with other NCEP administrators on actions executed and the impact on other areas.May provide support to the Quality Director in his/her responsibilities. Authorized to sign as the Quality Director designee or representative in his/her absence or as required.Participate in the PIR (Product Inquiry Report) process, assuring: diligent execution of activities related to the PIR, PIR assessment in the eCAPA system, PIR execution, and appropriate process communication to Corporation. May act as the Quality Director (Head of Quality) designee in PIR process activities.May provide guidance and supervision to process validation areas, software validation complaint handling, MTAC, Calibration, Microbiology, supplier, Q process development, and/or design assurance.What We’re Looking For:Licenciature degree in Industrial, Electronic, Biotechnology, Electromechanical Engineering or Field Related.At least 10 years of experience in similar position.Desired knowledge: Formal training on statistical and quality techniques, desirable ASQ Certified, Knowledge of Six Sigma, Lean, APQP or similar tools.Or an equivalent combination of education and experience.Requisition ID:
588617As 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.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, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
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