Boston Scientific Quality Specialist - P1 

United States, Puerto Rico 

414307167

Specialist I, Quality

Serve as Quality representative on product/process quality initiatives in support of manufacturing activities and other quality goals and priorities. Collaborates cross-functionally in the execution of projects designed to improve the compliance, efficiency and effectiveness of specific quality system elements. Provides guidance and/or mentorship in CAPA systems and related processes.

• Support departmental or cross-functional quality initiatives or projects by applying technical and quality system principles.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, investigating and resolving quality issues.
• Assist site's leadership in the collection, review, trending and/or reporting of quality data in support of Management Review.
• Provide direction and mentoring to CAPA/NCEP owners, including timely tracking, follow up and closure of NCEPs/CAPAs in their different phases.
• Interpret applicable internal and external regulatory requirements, regulations, and standards, as applicable.
• Participate cross functionally in global quality system projects and/or harmonization initiatives.
• Participate in internal and/or external audits as required by Management.
• Educate functional areas on quality system requirements.
• Other duties as necessary or required by the department or site.

Management Requirements

• Bachelor’s Degree in science or Engineering preferred and 3+ years of related work experience.
• Experience working in manufacturing area, Neuromodulation preferred.
• Understanding of product design concept with applicability on manufacturing environment.
• Knowledge in Quality Systems and Identification Traceability Systems (e.g. eCAPA, Windchill, MES, SAP, IQS, etc).
• General knowledge in quality metrics.
• Experience in problem solving activities, identification of root causes and understanding corrective and preventive actions.
• Willing to work different shits (1st, 2nd, 3rd and/or weekends) as needed
• Fully Bilingual

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.