At Boston Scientific, the business problem is to develop, establish and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements to support departmental, functional, site, divisional and corporate quality goals and priorities.
Requirements
- Experience working with Process Validation and Verification activities and risk management documentation such as Design/Process FMEAs
- Knowledge of analytical techniques and statistical analysis
- Knowledge of basic Quality Systems and good documentation practices
- Proficient with Microsoft Office tools including Word, Excel, Powerpoint, and Outlook.
- Familiarity with product/component documentation, inspection and testing, and Manufacturing Execution System (MES)
- Experience in medical device field in a manufacturing support role a plus
- Demonstrated experience managing multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines.
Responsibilities
- Provides leadership role on championing departmental or cross-functional engineering initiatives.
- Provides project direction, coaching, and mentoring for engineering and technical team personnel.
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
- Mentor for technical guidance for identifying and resolving quality issues.
- Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Other
- Bachelor’s degree
- Minimum of 3 years of relevant work experience
- Good written and verbal communication skills.
- Must be able to work independently under limited supervision
- Comfort speaking to groups of individuals. Presentation skills that comfortably and concisely translate manufacturing performance and issues to peer and senior management audiences.
