Sr. Quality Engineer - Medical Devices

Biotechnology and Pharmaceutical Sr. Quality Engineer - Medical Devices Job Description:General Summary: This position supports the quality and compliance of Electrophysiology and Cryovascular Medical Devices at Boston Scientific's San Jose facility. Designs, installs and evaluates quality assurance process sampling systems, procedures and statistical techniques; designs or specifies inspection and testing mechanisms and equipment; analyzes production and service limitations and standards; recommends revision of specifications when indicated. 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. Interfaces with all other engineering components within the company and with customers and suppliers on quality related issues. 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. Provides focused quality engineering support within new product development, operational, or system/services support. 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). 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 designed to meet or exceed internal and external requirements. Establish effective corrective action plans Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues Participates as leader or resource in validations applicable to processes and product. Leads and participates in MRB meetings (Purchased materials and in-house manufactured product). Identify non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems. Perform vendor Q.A. facility audits and administer any resultant corrective action programs Prepare Vendor QA/Inspection protocols for Ship-to-Stock program. Utilize standard and advance statistical analysis techniques to determine product acceptance, evaluate process capabilities, and developing statistically sound tolerance limits. Develop, refine and document QA Test and Inspection procedures. Select and order equipment as required. Evaluate and recommend QA sampling plans based on desired confidence limits, process capabilities, and manufacturing/inspection methods and equipment. Develop SPC applications in manufacturing. Set up programs and evaluate results. Provide technical guidance and training to QA department members in statistical analysis techniques, experimental design and other QA Engineering areas of expertise. Represent Q.A. Engineering during New Product Development and Design Review. Actively participate in all aspects of Design Control Provide consulting service 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. Position Qualifications: 5 - 8 Years experience with BS in Quality Engineering or related discipline. 1-3 years medical device experience required. Strong written/verbal communication skills. Demonstrated used of Quality tools/methodologies.Minimum Education Required: BachelorYears of Experience Required: More than 5 yearsExpected Travel Time: None Please visit us online at www.bostonscientific.com for more information.