Additional Locations: (n/a)
Purpose and Passion Comprehensive Benefits Life-Work Integration Community Career Growth
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 purposeimproving lives through your life's work.
This position has the option to be based remotely
About the role:
Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support. Serve as technical expert in the EtO sterilization, Radiation, Steam, Chemical and other Sterilization modalities
Your responsibilities include:
Provides leadership role on championing departmental or cross-functional engineering initiatives.Provide sterilization assurance and engineering support to manufacturing operations
Provides project direction, coaching, and mentoring for engineering and technical team personnel.
Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
Mentor for technical guidance for identifying and resolving quality issues.
Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.
What we're looking for in you:
BS in Engineering or Microbiology
8-13 years of quality and/or operations experience
Ability to travel 25-30% approx 50% domestic/50% international
Demonstrated expertise in ethylene oxide sterilization processes; knowledgeable in e-beam, Gamma, terminal liquid chemical sterilization, steam sterilization, reprocessed devices, etc.
Subject Matter Expert for FDA, ISO, MDD and and/or quality requirements associated with developing medical device
Working understanding of US and International regulations associated with all modes of sterilization
Experience with IQ, OQ and PQ processes
Experience with lean manufacturing and Sterilization Best Practices
Strong trouble shooting and problem solving skills
Excellent communication and presentation skills
Pro-active, energetic, self-assured professional with high personal integrity and ability to collaborate, influence and develop positive interpersonal relationships
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 439187