Quality Engineer, Point of Care

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Under the supervision of the Senior Manager Quality Assurance (QA) and Quality Control (QC), the Quality Engineer is responsible for performing tasks to ensure the maintenance of quality and compliance for Siemens Healthineers Point of Care Manufacturing in Walpole.

• This includes day to day support of the manufacturing lines, quality related aspects of raw material entering the site, and non-conformances that may be generated.

• Specifically, you will be required to interact and collaborate with cross-functional teams to promote and drive Quality Systems compliance regarding Quality Notifications and Temporary Manufacturing Deviations.

• The role works closely with the manufacturing, engineering, and procurement teams to assure compliance with all appropriate regulations and specifications.

• Prompt responsiveness is a requirement to avoid downtime.

• You will be expected to apply problem solving and interpersonal skills and be able to influence and drive results.

Responsibilities 
•    Performs review and approval of manufacturing batch records, detects problems/ non-conformances and quarantines non-conforming material in accordance with established procedures.
•    Ensures timely and compliant release of product to meet business demands.
•    Performs review and approval on behalf of Quality Control on new/ revised procedures, chemical qualifications and other documents as needed. 
•    Supports other functions in the writing and execution of Quality Notifications and Temporary

Manufacturing Deviations, providing guidance and training as needed.
•    Serves as Quality Notification coordinator.
•    Responsible for incoming inspection activities for POC Walpole manufacturing.
•    Interacts with multiple functions across sites including Engineering, Manufacturing, Technical

Operations, and Regulatory Compliance.
•    Become Subject Matter Expert on all aspects of each raw material.
•    Leads the material review process to resolve material non-conformances.
•    Participates as a manufacturing Subject Matter Expert on any process change to assure that proper documentation, validations, and/or qualifications are performed.
•    Responsible for assuring prompt completion of process related quality notifications and tracking/reporting all necessary tasks to assure completion. 
•    Participate in root cause investigations.
•    Participate in CAPA Review Board as required.
•    Participate in Validation Review Board as required.
•    Able to effectively communicate with internal and external customers.
•    Escalates issues to management as needed.
•    Supports other projects/topics, as assigned.
•    Attends meetings as Quality representative when manager is not available.
•    Understands and follows all cGMP and cGDP requirements. 
•    Participates in and contributes to a safe working environment.

Required Knowledge/Skills, Education, and Experience
•    University degree or a combination of education and technical experience
•    3-5 years of industry experience in an ISO 13485 or cGMP medical device manufacturing environment
•    Ability to work effectively within a team environment while satisfying individual responsibilities and objectives
•    Excellent high level oral and written communications skills 
•    Demonstrate and apply a broad knowledge of field of specialization and knowledge of fundamental concepts and practices
•    Demonstrate knowledge of organization's business practices and issues
•    Demonstrates a willingness to collaborate across teams and job functions and ensures clear communication to support manufacturing and suppliers 
•    Ensures compliance while meeting business objectives
•    Strong understanding of QMS requirements
•    Adaptable and willing to take on new tasks and responsibilities

Preferred Knowledge/Skills, Education, and Experience

•    Experience working in a GMP/ ISO point of care medical device manufacturing environment 
•    Additional medical device quality engineering experience is a plus
•    Proficiency with documentation of batch records and non-conformance/deviation records

 

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