Quality Engineer 4
Business Unit: Point of Care
Requisition Number: 234743
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 5%
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.
This position manages the Quality Assurance (QA) and Quality Engineering (QE) responsibilities supporting Point of Care (POC) manufacturing at the East Walpole facility. The individual in this role will be responsible for ensuring compliance with global and site specific quality system requirements, as well as applicable external regulatory requirements. In addition to interacting with and influencing the local manufacturing organization, this position interacts with representatives from HQ POC Quality, site LD Quality, HQ POC Regulatory Affairs and Engineering.
The primary responsibility is to ensure an effective and compliant Quality System is maintained to support the manufacture and distribution of quality products. This position is based in Walpole, MA and reports to the Director of POC Manufacturing.
Specific responsibilities include:
· Drive process measurement initiatives, including scorecards and other metrics, used to drive process improvements aimed at preventing field corrections related to manufacturing processes
· Support the investigation and resolution of manufacturing issues while ensuring that communication is effective, information is provided in a timely manner, and decisions are compliant
· Share best practices across the site and/or the business segment including other POC SCM sites
· Represent Walpole POC at Quality Management Meetings (QMM), Change Review Board (CRB) and Validation Review Board (VRB) meetings
· Assist in site’s internal audit program
Required Knowledge/Skills, Education, and Experience
Experience: A minimum of 5-8 years in the medical device or pharmaceutical/biotech industry with at least 3 years in a quality system management role.
An excellent understanding and practical application of medical device quality system regulations, e.g., 21 CFR 820, ISO 13485 and ISO 14971
Prior IVDD experience desirable
Education: A minimum of a 4 year degree, preferably in an engineering or science discipline.
Preferred Knowledge/Skills, Education, and Experience
· Strong oral and written communication skills and adept at establishing interpersonal relationships.
· Proven ability to work in a team environment, balancing compliance risk with business need.
· Proven ability to identify and implement improvements in manufacturing and quality processes that are efficient, sustainable and compliant.