Quality Systems Manager
- 300 Bear Hill Rd, Waltham, MA 02451, USA
Boston Engineering provides product design and engineering consulting across the entire product development process. The Company serves consumer products, defense & security, medical devices, robotics, and industrial markets. Founded in 1995, Boston Engineering is headquartered in Waltham, Mass. Learn more at www.boston-engineering.com.You can make a difference in the way people live and work by applying your experience and know how to our projects.
We are currently seeking a Quality Systems Manager to drive improvements in organizational performance, own all aspects of the Quality Management System and provide quality engineering support on projects.
- Communicate with internal and external stakeholders to support the Company’s programs and demonstrate its commitment to maintaining Quality integrity
- Ensure Quality Management System (QMS) harmonization with ISO 13485 and ISO 9001 requirements
- Consult as the quality team member on design and development projects both internally and in client engagements
- Monitor proactively and interpret external standards
- BS degree in an engineering field with an advanced degree or certifications preferred
- Demonstrated experience in the development and implementation of QMS to ISO 13485 and 9001 standards
- Ability to interact with, influence, and lead cross-functional cross-business unit teams
- Demonstrated project team experience in a quality engineering role
- Demonstrated passion for engineering and excellence
- Expertise in GMP/GAMP 5 compliance, Quality Systems, and Quality Risk Management
- Proficient in MS Office, MS Project, and MS Visio along with excellent written/verbal communication skills
- Desire to work in tandem with business leaders to develop, deploy, and maintain a comprehensive continuous improvement/operational excellence program
- Must be a US Person due to government contractual obligations
Boston Engineering provides product design and engineering consulting across the entire product development process. To improve how people work and live, Boston Engineering applies expertise from its precision engineering, advanced R&D, and global PLM infrastructure offerings. Certified for ISO 9001 and ISO 13485, the firm serves consumer products, defense & security, medical devices, robotics, and industrial markets. Founded in 1995, Boston Engineering is headquartered in Waltham, Mass.
Boston Engineering offers a full employee benefit plan including matching 401K plan in an open, energetic working environment that fosters strong client relationships and an entrepreneurial team spirit. Preference will be given to local candidates.
All your information will be kept confidential according to EEO guidelines.