Boston Scientific Quality Eng - P3 

United States, Puerto Rico 

407529849

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.

Responsibilities

• Quality Assurance support for Neuromodulation commercial products, with a focus on Non-Conformance Event Prevention (NCEP) and Correction and Preventive Action (CAPA).
• Collaborate with functional team members to perform product failure and complaint investigations for complaints, NCEP, CAPA, and/or audit findings.
• Coordinate product containment tasks for impacted materials and document activities.
• Assess product, packaging, and labeling design change impacts and risks.
• Design and implement Quality System processes, procedures, and techniques such as risk assessments, root cause analysis, etc.
• Represent as a design/quality resource for the Neuromodulation division at the manufacturing site. Communicate, coordinate, and act as a liaison between design and manufacturing. Collaborate with Operations teams to resolve product and process issues.
• Assess component criticality based on risk criteria and information.
• Work with supplier management teams to coordinate/assess supplier issues, process changes, and new supplier qualifications.
• Monitor and track the progress of quality-related tasks and initiatives. Collaborate and follow up with team members to ensure completion of assigned tasks within established timelines.
• Primary technologies/products of responsibility will be surgical accessories/tools and leads used for Spinal Cord Stimulation (SCS) and Deep Brain Stimulation (DBS).

• Identifies and resolves complex exceptions to work assignments.
• Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
• Read and interpret technical drawings, procedures, and protocols
• 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 respons
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• 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.
• Continually seeks to drive improvements in product and process quality.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Evaluates new equipment and processes and participates in the transfer of new products.
• Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality deci
• Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.

Maximum Salary: $ 110400

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.