Principal Quality Systems Engineer
Applying expertise on BSCs Quality Planning, coordinate Quality System Governance Board process to facilitate and promote sponsorship, strategic decisions, and issue resolution for programs, projects and emerging regulatory issues impacting BSC Quality System.
Identify and advise on potential improvements or enhancement to quality systems and processes in the company, including leading key global strategic projects. Using knowledge of Boston Scientifics Management Controls Standards and Regulations and Management Controls to act as a primary liaison to critical Notified Bodies.
As applicable, own corporate Corrective Actions and Preventive Actions (CAPA) and mentor team members on the CAPA process. Assist with maintaining and updating corporate certifications with Notified Bodies and providing subject matter expertise on how certifications should be managed following various changes to BSC organization/structure.
Lead global value improvement projects to increase process agility and reduce cost of operation. May require to travel/telecommute.
REQUIREMENTS: Employer requires a Bachelors degree in Engineering(any) or a related technical field plus 24 months experience in job offered, Quality Systems Engineer or related occupation. 1) Quality System integration, 2) BSCs Corrective Actions and Preventive Actions Processes & System (eCAPA), 3) Quality Systems External Audits preparation, 4) EU MDR Implementation and maintenance, 5) ISO 13485 Quality System Management 6) Quality Systems changes assessment 7) Coordinating local site CAPA program and mentoring team members on CAPA process, 8) as Assessment of product and process non-conforming events and develop corrective actions, and 9) Windchill Process Library.
WORKSITE: 300 Boston Scientific Way, Marlborough, MA 01752SALARY: From $82,306 to $137,261 per year
CONTACT: Susan Cardinal, Boston Scientific Corporation, Please include reference H4872-00881. (EOE).