Senior Quality Engineer

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

 

About the role:

 

Responsible for providing technical acumen and leadership to the Irvine, CA Sacral Neuromodulation manufacturing site with a significant focus on production / operations quality. This will include support for in-process inspection, final inspection, final product release activities, and will lead investigation and resolution of nonconformances. This role will also support post-acquisition quality systems integration activities as well as product transfer projects.

 

Ideal candidates will have direct experience with product line support in a medical device manufacturing environment (preferably Class III), actively engaged with day-to-day production activities alongside Operations Engineers, Supervisors, and production personnel. Direct experience with process and equipment qualification / validation, sterile barrier packaging, labeling, and ethylene oxide (EtO) sterilization processes is preferred.

 

Will identify, coordinate, and execute project priorities based on business and department objectives and at times at the Global BSC level.  Responsible for identifying and implementing continuous improvements to improve process performance and efficiencies.  This role provides significant visibility across site and divisional leadership. 

 

 At Boston Scientific, we value collaboration and synergy. This role follows an on site model requiring employees to be in Irvine, CA five days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

 

Your responsibilities will include:

• Developing and implementing quality inspection procedures including sampling plans, for production level components, sub-assemblies and finished goods. May also be responsible for the development and implementation of inspection methodologies, fixtures, measurement systems and calibration of such.
• Providing input regarding appropriate statistical methods, test methodologies, test facilities and equipment. Coordination of testing and management of resulting documentation and records. This can include process validation, equipment installation/operational qualification, test method validation, etc.
• 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.

 

 

Required qualifications:

• Bachelor’s degree in Engineering or other related scientific discipline
• Minimum of 3 years of related experience
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards.

 

Preferred qualifications:

• 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.
• Strong business acumen and communication skills, with the ability to quickly establish impact and consequences
• Ability to col