Purpose Statement:

Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.



Job Description:

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.



Job Requirements:

Minimum Degree in Engineering field.

At least 9 years of working experience in Operations Quality. Prior experience in the medical device industry is preferred.

Resolves issues using standard problem-solving tools and a strong understanding of quality operations fundamentals, including product risk assessment and data analysis to identify root causes and drive solutions. Communicates findings clearly and effectively. cross-functional management

Experience in product transfer will be added advantage.