Senior QA Engineer Job
Maple Grove, MN 
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Job Description

Additional Locations: US-MA-Marlborough; US-MN-Arden Hills

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.

Senior QA Engineer

About This Role:

A member of the Global Field Action organization that supports execution of product traceability reports to assist with advisories, corrections and removals globally. Serves as the SME of current product location, distribution and consumption quantities. Mentors investigation teams and field action coordinators on product information and actions required. Strong working knowledge of SAP and attention to detail will make an individual successful in this role.

Your Responsibilities Will Include:

  • Support the business by executing product traceability reports that help identify product location and drive the appropriate investigation and actions. Provides direction, coaching, and mentoring for analysts and divisional investigation teams.
  • Expertise within the SAP system to confirm outputs in traceability reports are accurate and supplemented as needed. Ability to provide detailed reports to identify current location of serialized devices.
  • Understanding of product movements throughout BSC manufacturing sites, plants and distribution centers to be able to monitor inventory and accurately report consumption and distribution information to FDA under 806 reporting requirements.
  • Knowledge and assistance with placing and removing quality controls that prevent device movement during quality investigations and recalls.
  • 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:

Minimum Qualifications

  • Bachelor’s Degree in the Engineering or Science field, plus 6-9 years of related experience or an equivalent combination of education and work experience.
  • Comprehensive understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485.
  • Strong analytical skills, working knowledge of SAP application and attention to detail.
  • Strong communication skills and comfortable speaking and presenting to leadership
  • Flexible and positive attitude

Preferred Qualifications

  • Experience with recalls/field action processes
  • Experience with CAPA and External Audits
  • Project management

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

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code * 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Requisition ID: 468316

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
6 to 9 years
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