Senior Quality Systems Engineer at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

30 Jan, 26

Salary

0.0

Posted On

01 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Systems, CAPA Processes, Technical Guidance, Quality Management Review, Auditing, KPI Reporting, Corrective Actions, Preventive Actions, Regulatory Compliance, Continuous Improvement, Team Leadership, Quality Assurance, Quality Engineering, Medical Device Industry, MS Office, Problem Solving

Industry

Medical Equipment Manufacturing

Description

Provides cross-divisional Quality Systems support through the coordination of various elements within the Quality System Management and CAPA processes within the BSC Global Quality System. Provides technical guidance and leadership to Quality Systems and other personnel on compliance with BSC and external requirements. 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 provides cross-divisional Quality Systems support and coordinates various elements within the Quality System Management and CAPA processes. They also act as a Lead or Support Auditor and support external audits, while championing continuous improvement within the department.