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Quality Manager I Job

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Date: Jul 11, 2019

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific




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.




About This Role:

Leads the team of Quality engineers to effectively monitor, identify and escalate field signals.   Empower team to create, maintain and validate the necessary tools for completion of these tasks.  Partner with IT to provide necessary tools.  Work with internal and external customers to provide the required Regulatory Reports, Monitoring reports, adhoc data and CAPA analysis required.



Your Responsibilities Will Include:

  • Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources
  • Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
  • Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
  • Provide vision and plans for future improvements.
  • Utilize big data and text analytics to recognize patterns, trends and information in unstructured data.
  • Facilitate the monitoring of new products and their performance during early commercial release.
  • Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
  • Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
  • Translates department goals into individual objectives.
  • Identifies, develops and implements processes to improve department performance.
  • Monitors departments activities and records to ensure compliance independent action through critical decision making.
  • Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.



What We’re Looking For In You:

Minimum Qualifications

  • Bachelor's degree plus 4-6 years of related work experience or an equivalent combination of education and work experience.
  • 2+ years of direct supervisory experience with a passion for leadership and developing people
  • Medical Device or regulated industry experience
  • Experience in the NCEP and CAPA process including department process management and documentation
  • Strong verbal, written communication skills, both technical and conversational
  • Decision making and negotiation skills, individually and within groups
  • Experience in managing multiple projects across multiple organizational disciplines
  • Strong technical knowledge of BSC implantable and remote monitoring products

Preferred Qualifications

  • Engineering degree or strong clinical experience
  • Advanced degrees or statistical acumen
  • Collaborative leader with experience leading technical teams
  • 2-3 years of PMQA time with leadership experience
  • Experience with Risk Assessment process and documentation
  • Change Management experience
  • Project Management experience from project inception through delivery and maintenance
  • Demonstrated success in the audit process and use of audit controls
  • Software validation experience
  • Data analysis capability




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: 448628


Nearest Major Market: Minneapolis

Job Segment: Medical, Engineer, Law, CAPA, Quality, Healthcare, Engineering, Legal, Management