Senior Quality Engineer Job in San Jose 95101, California US
Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Senior Quality Engineer
Job Description:
General Summary:
The Sr. Quality Engineer is responsible for providing Quality Engineering support to Manufacturing, Manufacturing Engineering, RD activities, and Post Market Compliance. Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.
Serves as a Quality representative to improve awareness, visibility and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. May conduct training on quality assurance concepts and tools. Interface with other functional groups within the company on quality related issues.
Specific Duties and Responsibilities:
§Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).
§Provides leadership not only from a Quality and Compliance perspective but also from the business need perspective
§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.
§Collects quality metrics, identifies areas for quality improvement and institutes programs to improve customer satisfaction.
§Develops, implements, and coordinates plans to prevent or reduce defects in new or existing products working with the Engineering functions
§Root Cause Analysis of product non-conformances as discovered by Manufacturing and Customers.
§Lead development and improvements to business systems which effectively identify and resolve quality issues
§Participates in validations including, but not limited to, new products, changes to existing products, processes, and equipment.
§Identify non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems.
§Utilize standard and advance statistical analysis techniques to determine product acceptance, evaluate process capabilities, and developing statistically sound tolerance limits.
§Evaluate and recommend sampling plans based on desired confidence limits, process capabilities, and manufacturing/inspection methods and equipment.
§Provide consulting and technical guidance to other departments on the use of statistical methods in Design of Experiments, Data Analysis, Sampling Techniques, etc.
§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.
Working Conditions:
The majority of the work will be spent in an office and cleanroomenvironment.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification.They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
Job Experience:
Position Qualifications:
5 - 8 Years experience with BS in Quality Engineering or related discipline, or equivalent combination of education and experience to perform at this level.
1-3 years medical device experience required.
Strong written/verbal communication skills.
Demonstrated used of Quality tools/methodologies.
Years of Experience Required: More than 5 years
Expected Travel Time: None
This company may offer relocation assistance.