Senior Quality Engineer

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 or higher, preferably in an Engineering discipline.
• Minimum 9 years of experience in Operations Quality. Prior experience in the medical device industry is preferred.
• Strong understanding of quality operations fundamentals, regulatory requirements, and quality systems.
• Experience working in regulated manufacturing environments.
• Strong analytical thinking and decision-making capabilities with the ability to solve complex quality issues.
• Ability to work effectively across multiple functions and stakeholders.

Required Skills

• Resolves issues using standard problem-solving tools and a strong understanding of quality operations fundamentals.
• Product risk assessment.
• Data analysis to identify root causes and drive solutions.
• Effective communication of findings and recommendations.
• CAPA, NCEP, and Failure Mode Investigation experience.
• Validation engineering and process validation expertise.
• QSR, ISO, and Medical Device regulatory knowledge.
• Root cause analysis and corrective/preventive action implementation.
• Technical review and approval of operational, test, and validation data.
• Cross-functional collaboration and stakeholder management.
• Supplier quality and customer complaint investigation experience.
• Experience in product transfer will be an added advantage.