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Senior Quality Engineer - Defined Term - 2 Yrs Job

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Date: Dec 6, 2018

Location: San Jose, CA, US, 95101

Company: Boston Scientific

Primary Location: [[filter2]]
Additional Locations: (n/a)
 

 

 

Please note this is a defined term position of approximately 2 yr. duration. Defined term employees are eligible for most benefits including paid vacation, holidays, 401k matching and healthcare benefits.

 

About this 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.

 

Your Responsibilities:

  • Provides leadership role on New Product introduction (NPI), product transfer, and acquisition deliverables.  (Process V&V)
  • Provides leadership role on championing departmental or cross-functional engineering initiatives.
  • 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 are looking for:

 

Basic Qualifications:

  • Bachelor's degree in Engineering or Quality with 5-8 years of relevant experience OR Master’s degree with 3-6 years of relevant experience.
  • Medical device experience and preferably with capital equipment.
  • Experience in supporting Quality related activities and leadership.
  • Strong analytical skills.
  • Motivated self-starter.
  • Strong written and verbal communication skills.

     

    Preferred Qualifications:

  • Experience with supporting Verification and Validation activities.
  • Problem solver with the knowledge of problem solving tools, capable of facilitating problem solving process.
  • CQE/CQA certification

 

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.

  • 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.
     

     

 

Boston Scientific is an Equal Opportunity Employer.

 

Posting Notes: [[filter2]]||(n/a)||Quality||[[mfield2]]


Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto

Job Segment: Quality Engineer, Medical, Manufacturing Engineer, Engineer, Engineering, Healthcare, Quality