Quality Engineers are primarily responsible for all quality related aspects of raw material entering the plant. This includes day to day support of the manufacturing line, problems that occur, and non-conformance that may be generated. The role works closely with the manufacturing and engineering teams to assure compliance with all appropriate regulations and specifications. Prompt responsiveness is a requirement to avoid downtime.
Duties and Responsibilities:
- Support design transfer of new production coming into the facility, including raw material specification development, supplier audits and supplier monitoring/qualification, development of incoming inspection processes, and support of existing products
- Interact with multiple functions across sites including Engineering, Manufacturing, Technical Operations, and Regulatory Compliance
- Become Subject Matter Experts on all aspects of each raw material
- Lead the MRB process to resolve material non-conformances
- Write or revise necessary production-controlled documents as needed
- Participate 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. Serve as Quality Notification coordinator
- Participate in root cause investigations.
- Participate in CAPA Review Board as required
- Participate in Validation Review Board as required
- Prepare for FDA inspections and registrar audits
- Issues the requirements for change request management in the projects and provides if necessary suitable methods.
- Provides procedural support for the engineering organization at e.g.:
- May actively execute or initiate internal quality measures (e.g. formal checks of data bases or documentations).
- Able to effectively communicate with internal and external customers
Required Knowledge/Skills, Education, and Experience:
- Preferred Bachelors Science – Industrial Engineering
- Also acceptable with equivalent experience: Other engineering or science degree
- Seeking immunoassay experience with microfluidics, protein chemistry, and ELISA
- 10 years’ experience in the medical device/pharmaceutical industry with background in supplier quality. Knowledgeable of all industry regulations and requirements
- Process Control Technology experience is helpful
- Statistical knowledge and Design of Experiments experience
- Strong procedure development/technical writing skills
- Value Stream Mapping/Lean experience is helpful
- Strong communications background, both written and verbal
- ASQC Certifications helpful
Other characteristics of the successful candidate:
· Very organized, detail-oriented
· Highly self-motivated
· Able to work independently
· Excellent analytical, communication, writing, and problem-solving skills
· Effective and influential in his/her interactions in team-based assignments
· Able to work well with personnel from different departments, and experience levels
· Ability for potential international travel from time to time
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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