Boston Scientific is looking to solve health industry challenges by providing technical acumen and leadership to the Irvine, CA Sacral Neuromodulation manufacturing site with a focus on production/operations quality.
Requirements
- Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards.
- Experience in Medical Device industry
- Demonstrated effective change leadership and results-oriented focus
- Demonstrated problem-solving & data analysis capabilities
- Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
- Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis
- Self-starter with the ability to identify improvement opportunities.
Responsibilities
- Developing and implementing quality inspection procedures including sampling plans, for production level components, sub-assemblies and finished goods.
- Providing input regarding appropriate statistical methods, test methodologies, test facilities and equipment.
- Conducting product and process nonconformance investigations and may include NCEP & CAPA ownership.
- Mentoring junior engineers and investigators by providing technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques.
- Ensures compliance with company quality policies and practices by participating in product and material reviews, assist in resolving problems related to the Manufacture, test, validation, and documentation.
- Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Other
- Bachelor’s degree in Engineering or other related scientific discipline
- Minimum of 3 years of related experience
- Strong business acumen and communication skills, with the ability to quickly establish impact and consequences
- Ability to collaborate and influence across multiple, cross-functional teams
- Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
