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Senior Quality Systems Engineer Job

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Date: Aug 9, 2019

Location: Cambridge, MA, US, 02138

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.

 

About the role:

In this highly visible role as the Quality System representative at the Cambridge site, you will have primary responsibility for the site’s Quality System while also benefiting from personal and professional growth resulting from collaboration with divisional and corporate partners and from gaining auditor facing experience. 

 

Cambridge is a dynamic R&D site with a strong track record of high performance against quality metrics and product development goals.

 

Your responsibilities include:

• As Quality Systems Lead in Cambridge, support and maintain quality system methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.  The Quality System in Cambridge comprises Management Controls, Internal Audit, Document and Record Controls, Design Controls, Post Market Support and CAPA. 

• Own important Quality System responsibilities such as Quality Management Review, CAPA review, Internal and External Audits, Non-Conforming Events, Non-Conforming Materials, Non-Conforming Products, CAPA and Field Actions. Mentor personnel involved in those activities.

• Act as primary representative for external audits.  Establish and meet the Internal Audit schedule.  Collaborate with other BSC sites to provide personnel to conduct Internal Audits in Cambridge as needed.  Participate as auditor for internal audits at sister sites.

• Improve awareness, clarity, and communication on quality initiatives in support of departmental, functional, site, divisional and corporate quality goals and priorities.

• Collaborate with members of Quality Systems Teams at our partner sites including Arden Hills, MN, Heredia, Cost Rica and Marlboro, MA.

• Work to become an expert in the Boston Scientific Global CAPA System and mentor personnel involved in those activities.

• Interact and partner with Division Management, subject matter experts, corporate stewards and other personnel who support the Boston Scientific Global Quality Systems.

• Own Quality System Reports, Records and slide decks used to support official presentations to the Cambridge Site Management, Division Management and Corporate Quality.

• Complete trend analysis and capture metrics for reports including non-conformance records, corrective action records, training records and audit records.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Advise management on potential improvements or enhancement to quality systems and processes in the company.

 

What we are looking for in you:

Minimum qualifications:

• BS in Engineering or related technical discipline

• 5+ years of related Medical Device experience

• Ability to work in a fast paced, dynamic environment

• Team player

• High energy problem solver capable of driving items to closure

 

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: 450587

 


Nearest Major Market: Cambridge
Nearest Secondary Market: Boston

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