Siemens Careers

Quality Engineer 5

Norwood, Massachusetts
Quality Management

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Point of Care
Requisition Number: 228060
Primary Location: United States-Massachusetts-Norwood
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%

Division Description:

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably.  A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.

 

Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape

Job Description:

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably.  A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics. 

Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.

 

Role Summary:

·       Responsible for post market regulatory compliance and vigilance reporting for the POC Business Area products.

·       Prepare, manage and lead Product Quality Committee (PQC) activities for POC products.

·       Represent the QM function for POC Escalated Review Council (ERC) meetings.

·       Review and approve all Medical Device Reports (MDRs) and Medical Device Vigilance Reports (MDVRs) prior to filing.

·       Primary correspondent with FDA regarding POC compliance related issues. This includes Medical Device Records (MDRs), Recalls / Field Actions and requests for post market compliance / vigilance information. Provide initial, intermediate and final reports for the above as required by the regulations.

·       Primary correspondent with the Siemens EU Authorized Representatives to provide requested information regarding POC related Field Safety Corrective Actions (FSCAs), Medical Device Vigilance reports (MDVRs), and any additional post market vigilance information that is requested by the Country National Competent Authorities (NCAs). Provide initial, intermediate and final reports for the above as required by the regulations.

·       Track and enter correspondences and documents associated with the above activities into the appropriate databases, spreadsheets, and Documentum.

·       Lead activities and teams (as requested) that may lead to POC related post market regulatory interactions.

·       Assist in the preparation for and participate as required for external regulatory inspections (FDA, LRQA, etc.) and audits that occur at the Siemens Healthcare Edgewater, MA site to insure compliance to FDA, ISO, and other regulatory requirements. 

·       Provide support for external inspections and audits at other Siemens sites as requested.

·       Review and close CAPAs as assigned.

·       Provide QM Support for POC commercialized product as required.

 

Qualifications/Requirements:

 

·        Bachelor’s degree in related discipline, or advanced degree, where required, or equivalent combination of education and experience.

·        Minimum of 10 years of successful experience in related field and successful demonstration of key responsibilities and knowledge as presented above

 

 

 

Desired Characteristics and Experience:

 

·        Acts as advisor to top management and business partners on advanced technical matters. Represents the company as the primary external contact.

·        Develops team members through mentoring and coaching in complex subjects.

 

 

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