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Quality Manager II Job

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Date: Jun 30, 2019

Location: Menlo Park, CA, US, 94025

Company: Boston Scientific

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.


***Job Location is in Menlo Park***


About the role:
Leads metals (EDM/Electropolishing) Quality Engineering team to ensure the efficient production / assembly and distribution of reliable products in accordance with Global / site procedures and applicable regulations.  Collaborates with R&D and Manufacturing Engineering on new product introductions and sustaining projects.  Collaborates with sites located in Los Gatos, CA, Maple Grove, MN, Penang, Malaysia, and Galway, Ireland regarding component performance, continuous improvement projects, and input to feeder system and management reviews.


Your responsibilities include:

  • Leads, coaches, and develops department team members as necessary to support changing business needs
  • Works with the Operations and Manufacturing Engineering to drive continuous improvement through business and quality objectives
  • Provides Quality Engineering support for production; addresses non-conformances through the NCEP system, driving PIR escalation and PIR processes when risk level warrants it
  • Collaborates with cross-functional teams on new product introductions, transfers, and sustaining projects with a focus on Design for Manufacturability / Testability / Reliability
  • Leads Quality Planning activities related to Improvement projects, QMPs & other site projects as needed
  • Drives improvements in product quality based on out-of-box failure / complaint / in-process data analysis
  • Leads corrective and preventive actions as required; proactively identifies and executes on opportunities for preventive actions
  • Leads cost reduction projects, using Lean / Lean Business Process methodologies; contributes annually to the VIP savings program through Quality-driven projects as well as supporting projects driven by other functions
  • Participates in site internal and external audits; acts as Subject Matter Expert in Quality Engineering
  • Contributes to Quality Management Reviews
  • Ensures training plans and records for direct reports are compliant to Company-specific policies

Quality System Requirements

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

For those individuals that supervise others, the following statements are applicable:

  • 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


What we’re looking for:

Basic Qualifications

  • Bachelor’s degree
  • 7 years quality/operations experience, 3 years direct experience in a managerial role in Operations Quality within the medical device industry
  • Excellent interpersonal skills
  • Strong presentation skills and MS Office skills
  • Experience with major systems (e.g. eCAPA, Windchill, SAP, VIP) desirable
  • Strong analytical skills
  • Solid project management skills
  • Experience with Lean / Lean Business Process (LBP) methodology
  • Significant resourcing & budgeting experience
  • Demonstrated leadership ability
  • Conflict management and negotiation skills

Preferred Qualifications

  • Bachelors Degree in Engineering
  • 7+ years relevant experience; 3+ years direct experience in a managerial role in Operations Quality within the medical device industry; or equivalent combination of education and experience to perform at this level
    Experienced in legacy Boston Scientific’s business processes and Quality Systems



About us

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: 444480


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland

Job Segment: Medical, Engineer, ERP, Quality Manager, Quality, Healthcare, Engineering, Technology