Boston Scientific Quality Eng - P4 

United States, Puerto Rico 

538297258

Purpose

• Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.

Responsibilities

• Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for implementing product stops & documenting release criteria.
• Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analysis, FMEAs in conjunction with other product development team members. May be responsible for risk analyses and FMEAs.
• Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
• Collects and analyzes Leads Manufacturing process defect data Product/Process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development
• Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
• Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned.
• Responsible for the final Process Monitor Release for products prior to distribution.

Management Requirements

• 5-8 with BS or an equivalent combination of education and work experience
• 5-8 years of experience working within drug/medical device regulatory environment
• Knowledge of Medical Device Systems regulations (i.e 21 CFR 820)
• Experienced professional with understanding of Manufacturing Process defects evaluation and root cause identification
• Experience with CAPA Process and complex investigation
• Knowledge in Problem Solving & Process Improvement Techniques
• Experience in Manufacturing line transfers
• Experience with Risk Documentation (i.e FMEA)
• Experience/knowledge of Process Monitoring Systems

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.