Key Responsibilities

• Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
• Read and interpret technical drawings, procedures, and protocols.
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.
• Participates in Customer Complaints investigation for areas under their control.
• Document investigation findings in analysis report on GCS2.
• Become a trainer for the Software related with complaints handling process (GCS2), as required.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Demonstrates and actively promotes highest levels of professional QA engineering discipline and rigor.
• Is viewed as a leader in the areas of QSR and ISO/MDD standards within ones own group, constantly promotion awareness of best industry practices making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the final arbitrator on critical quality decision.
• Has significant expertise in validation engineering and is thoroughly familiar with all regulatory requirements.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Champions continuous improvement and innovation from a quality perspective within the department right from vendor selection/approval through to customer awareness/satisfaction.
• Is an effective team member, fully motivated to achieve and demonstrate best practices in line with the department and LRP objectives.
• Gives technical guidance to Quality Engineers, Associate Quality Engineers, technician and inspection staff.
• Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.
• Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise.
• Is familiar with the internal auditing process.

Requirements

• Bachelor's Degree in Engineering, Technology, or related Science.
• Minimum 4 to 5 years of relevant experience in a regulated industry, preferably within the medical device industry.
• Experience in reviewing and approving nonconforming event risk assessments and investigations.
• Strong understanding of quality systems, regulatory requirements, and validation processes.
• Strong analytical mindset with proven problem-solving capability.

Required Skills

• Good understanding of ISO 13485 requirements and QMS regulations.
• Experience running and reviewing nonconforming event risk assessments and investigations.
• Experience executing and supporting the full validation lifecycle, from planning to reporting.
• Strong analytical skills, problem-solving skills, including Root Cause Analysis (RCA).
• Statistical analysis skills using tools such as Excel and Minitab.
• CAPA, NCEP, Failure Mode Investigation, and nonconformance management.
• Validation engineering and process validation expertise.
• Customer complaint investigation and complaint handling experience.
• Technical documentation review and approval.
• Effective communication and cross-functional collaboration skills.