Senior Quality Systems Engineer

Senior Quality Systems Engineer

This is a senior role within the Marlborough Quality Systems group to maintain and improve the performance of the Quality function within the Marlborough site and across the Endoscopy and Urology & Pelvic Health divisions.

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. Liaise with cross functional SMEs to gather data in support of corporate and site goals and objectives. Drives a culture of continuous improvement and collaboration within the Quality Systems group.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities include:

• 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.

Required Qualifications:

• 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

Preferred Qualifications:

• 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)