Senior Quality Systems Engineer at Boston Scientific Corporation Malaysia

Coventry, Rhode Island, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Auditing, CAPA Coordination, Regulatory Knowledge, Continuous Improvement, Team Management, MS Office, Quality Assurance, Quality Engineering, Problem Solving, Medical Device Industry, ISO Standards, EU MDR, QSR, Cross Functional Collaboration, Complaint Review

Industry

Medical Equipment Manufacturing

Description

Coordination and preparation of Quality Management Review meetings for the Endoscopy and Urology & Pelvic Health divisions. Act as a Lead or Support Auditor for audits as necessary within the Marlborough Internal Audit Schedule. PIR Coordination for the Marlborough site. QN Coordination for the Marlborough site. Support external audits as required in either a backroom or front room role as required. Report on KPI and metric information as required to support divisional or site needs Support the site corrective and preventive actions process as a CAPA Coordinator or Mentor. Support the Complaints Review Board process as required. Act as an expert resource in external regulations and standard requirement knowledge for cross functional teams Ongoing maintenance and updates to Marlborough site level procedures. Champions continuous improvement and innovation from a quality perspective within the department. Supervision and management of other personnel, as required. Representation of Marlborough site on various Communities of Practice and active engagement in those communities. Bachelor's degree Engineering, Science or related technical discipline. Minimum of 5 years' of relevant experience in a regulated industry. Working knowledge and understanding of QSR, ISO and EU MDR and other medical device industry quality requirements. Strong command of MS Office - Word, Excel, PowerPoint, Visio Previous experience in Quality Assurance, Quality Engineering or Quality Systems background. Excellent written and verbal communication skills. Proven ability to work well as part of a team or alone with minimum supervision. Demonstrated ability to identify and work with cross functional organizations to solve problems. Ability to rapidly learn and use new applications Experience in the medical device industry Previous experience with BSC systems (Windchill, eCAPA, SAP, etc)

Responsibilities

The Senior Quality Systems Engineer will coordinate and prepare Quality Management Review meetings and act as a Lead or Support Auditor for audits. They will also support external audits, report on KPI and metrics, and champion continuous improvement within the department.