Senior Quality Engineer

Aerospace, shipbuilding, other transport equipment, Automotive, Electrical, optical, Engineering
Not specified
Contract type:
Full time
Salary description:
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Start Date:
Boston Scientific
Job Ref:

This position will provide quality engineering leadership and technical expertise in Complaint Investigation Site (CIS) within the Post Market Quality Assurance supporting multiple divisions throughout Boston Scientific. This role will assist in developing and refining failure analysis methodologies as a means of advancing comprehensive understanding of product performance to improve patient outcomes. This position will identify, analyze, investigate, monitor and document patterns and trends in complaint data. Communicate and educate management, R&D, Design Assurance, Ops Quality, Marketing, Sales and other departments about product performance and escalations. Ensure that information and insights gained from product investigations and corrective actions is fed back to the R&D, Design Assurance and Marketing organizations as part of the risk management and design input process. The person in this role should possess demonstrated ability to work in a cross-functional problem-solving capacity.

Your Responsibilities Will Include:

Lead development of methodologies and practices in CIS that will evolve overall capabilities and helps develops tactical approaches to implement team strategies.

Perform testing, in a laboratory setting, on returned medical devices associated with customer complaints to determine the most probable cause of the complaint, while ensuring timely closure. Documenting the product investigation activities clearly and accurately.

Analyze customer complaints, events and other post marketing surveillance data by examining the data for patterns and trends and investigating when necessary and working on cross-functional teams.

Provide direction and guidance for assigned tasks to meet department goals and objectives, ensuring that investigations applicable to product complaints and related records within the Global Complaints Management System are robust, with insightful conclusions that support product performance improvements.

Communicate product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization.

Provide direction, coaching, and mentoring to engineering and/or technical team personnel.

What Were Looking For In You:

Minimum Qualifications

Bachelor's degree in an Engineering discipline or related field of study

5+ years of relevant experience

Strong understanding of Complaint Handling processes and Complaint investigations

Advanced problem-solving skills - proven ability to identify and solve problems

Strong communication skills (verbal & written)

Preferred Qualifications

Understanding of external regulations FDA CFR 820, ISO 13485

Experience with Design Controls and Risk Management

Closing Date:
Contact Details:
Boston Scientific
Contact: Click apply

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