Posted: Thursday, February 8, 2018 12:39 AM
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 purpose-improving lives through your life's work.
Quality Manager II-Corporate Sterilization Services
About the role:
Leads globally located team of engineers and scientists to meet objectives of corporate sterilization services organization. Develops, establishes and maintains sterilization assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines. Reviews, analyzes and reports on quality discrepancies related to process and product systems and develops disposition and corrective actions for recurring discrepancies. May interface with manufacturing, engineering, vendor and subcontractor representatives to determine responsibilities and solutions. May serve as liaison between the company and the various governmental agencies. Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
Your responsibilities include:
:Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
:Establishes and promotes a work environment that supports the Quality Policy and Quality System.
:Ensures that all Sterilization processes are validated to required International standards and are in maintained in a State of compliance.
:Identifies and implements effective Sterilization systems to support the development, qualification, and on:going manufacturing of products to meet or exceed internal and external quality and regulatory requirements.
:Manages and provides oversight on Sterilization related CAPAs.
:Applies sound, systematic problem:solving methodologies in identifying, prioritizing, communicating, and resolving Sterilization related issues.
:Manages potential improvements and VIP opportunities within the Sterilization work stream.
:Provides project direction, coaching, development and mentoring for sterilization and technical team personnel .
:Supports Management Review at both corporate and site level.
:Participate in the planning for and execution of Sterilization requirements for Integration and Acquisitions.
:Supports and/orParticipates in Global Sterilization strategies for BSC, as required.
:Contributes to the development of Sterilization Standards through relevant working groups.
:Occasional domestic and international travel to other BSC facilities for meetings and/or conferences (10:25).
What we're looking for:
:BS in Science/Technical Field. MS preferred.
:8:10 years of related experience, 5:7 years in the medical device industry preferred.
:Proficient with Microsoft Office Suite and Minitab
:Excellent communication and presentation skills.
:Subject Matter Expert for FDA, ISO, MDD and and/or quality requirements associated with developing medical devices.
:Subject Matter Expert for US and International regulations associated with all modes of sterilization.
:Demonstrated expertise in ethylene oxide sterilization processes with a working understanding of e:beam, Gama and other sterilization methods.
:Demonstrated proficiency in staff leadership and development.
:Pro:active, energetic, self:a
• Location: maple grove, Minneapolis / St. paul
• Post ID: 29000917 minneapolis