Senior Quality Engineer

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.

Key Responsibilities

• Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
• Reads and interprets 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.
• Identifies 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 owners to bound product stops and document release criteria.
• Participates in customer complaints investigation for areas under their control.
• Documents investigation findings in analysis reports on GCS2.
• Becomes a trainer for the software related to complaints handling process (GCS2), as required.
• Checks and supports the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Demonstrates and actively promotes the highest levels of professional QA engineering discipline and rigor.
• Is viewed as a leader in QSR and ISO/MDD standards within their group, constantly promoting awareness of best industry practices and making appropriate decisions daily, using the guidance of the Quality Engineering Manager/Site QA Director.
• Possesses significant expertise in validation engineering and is thoroughly familiar with all regulatory requirements.
• 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, from vendor selection/approval through to customer satisfaction.
• Acts as an effective team member, fully motivated to achieve and demonstrate best practices aligned with departmental and LRP objectives.
• Provides technical guidance to Quality Engineers, Associate Quality Engineers, technicians, and inspection staff.
• Works with EHS to identify significant environmental impacts of operations and to establish related goals and targets.
• Engages with suppliers, other engineering disciplines within and outside the site, and customers as needed.
• Is familiar with the internal auditing process.

Job Requirements

• Candidate must have at least a Bachelor's Degree in Engineering, Mathematics, Statistics, Analytics, or other Science-related fields.
• Minimum of 8-10 years of experience in a regulated Quality System organization (ISO 9001/ISO 13485).
• Experience in Distribution Quality, Operations Quality, or Quality Systems is advantageous.
• Skills: Excellent influencing and communication skills, good team player, positive attitude, problem-solving abilities, and leadership qualities to lead issue investigations.
• Experience in the medical field is an added advantage.

About Us

As a global medical technology leader for over 40 years, Boston Scientific's mission is to transform lives through innovative medical solutions that improve patient health. If you aim to make a meaningful difference worldwide and locally, this is the place to do it.