Quality Engineer 3

Flanders, New Jersey, United States
20 Apr 2018
20 May 2018
Contract Type
Full Time
Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 224783
Primary Location: United States-New Jersey-Flanders
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 15%

Division Description:

At Siemens Healthineers, we are passionate about\nenabling healthcare professionals to deliver high quality patient care, and to\ndo so affordably. A leading global healthcare company, Siemens\nHealthineers continues to strengthen our portfolio of medical imaging and\nlaboratory diagnostics, while adding new offerings such as managed services,\nconsulting, and healthcare IT services - as well as further technologies in the\ngrowing market for therapeutic and molecular diagnostics.
\n\n Siemens Healthineers develops innovations that support\nbetter patient outcomes with greater efficiencies, giving providers the\nconfidence they need to meet the clinical, operational and financial challenges\nof a changing healthcare landscape

Job Description:

\n Reporting to Incoming Inspection/Final Release QC Manager, the Quality Engineer III will work with cross-functional teams to support resolution of compliance issues and managing/participating in various process improvement initiatives while maintaining focus on enforcing adherence to internal procedures and regulatory compliance standards.
\n The QE III position requires a mix of organizational skills, analytical problem solving skills, mechanical assembly knowledge, raw material properties knowledge, and molding and extrusion processes knowledge. This position requires excellent organizational skills and superior verbal and written communication skills.
\n Job Responsibilities:
\n Analyzes complex production and quality trend data to identify and solve problems. Devises sampling procedures and designs and develops systems for recording, evaluating, and reporting quality and reliability data
\n Enforces adherence to Company policies and procedures
\n Develops CMM programs for dimensional verification of gauges and components
\n Assists quality team members with capability and R&R studies as needed
\n Participates in CAPA program, change processes/continuous improvement projects
\n Conducts the analysis, inspection, design, test, and/or integration to assure the quality of assigned product or component
\n Supports departments in maintaining compliance with applicable standards and regulations
\n Completes and maintains quality inspection programs for incoming, process, and final approval material and product inspections
\n Supports development and execution of process validations (IQ, OQ, PQ and PPQ) while applying Six Sigma methodologies and statistical tools to investigate and solve issues
\n Education and Experience:
\n Bachelor's degree in Science or Engineering Field of study and 8-10 years' experience in medical device and quality fields
\n Special Requirements/Certifications:
\n In-depth knowledge of requirements and regulations related to ISO 13485
\n In-depth knowledge of requirements and regulations of FDA CFR for Medical Devices
\n CQA or CQE certification preferred but not required
\n In-depth knowledge of processing validation (IQ, OQ, PQ and PPQ)
\n Knowledge, Skills and Abilities:
\n Knowledge of ISO13485 standards for Medical Devices
\n Knowledge of FDA Code of Federal Regulations for Medical Devices
\n Extensive knowledge of quality control standards, practices, and applicable techniques
\n Knowledge of external quality audits and providing compliance support
\n Advanced knowledge of reports used in Quality Assurance and Quality Control
\n Proficient skills in mediating disagreements between departments
\n Proficient skills in SAP
\n CMM programming
\n Advanced knowledge in GD&T
\n Demonstrated attention to detail and accuracy
\n #LI-EM1

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