Quality Engineer I

Danaher

(Hatfield, Pennsylvania)
Full Time
Job Posting Details
About Danaher
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions.
Summary
This position will be responsible for a number of Quality Engineering functions within the Imaging business, primarily supporting daily Operations needs and identifying and driving the resolution of internal quality issues. This will be done through process and hardware verification/validation, supplier quality initiatives, leadership of Material Review Board meetings, and systemic improvements to the Quality Management System. This position will also be responsible for the review/approval of supplier data associated with product and specification changes, and will maintain the accuracy of calibration records and the calibration schedule.
Responsibilities
* Identify and drive the resolution of internal quality issues * Work with suppliers to improve and sustain quality improvements * Routinely compile and report key quality metrics data to multiple organizational levels * Lead routine Material Review Board (MRB) meetings to identify supplier quality issues and ensure timely disposition of nonconforming materials * Maintain accuracy of calibration records and calibration schedule * Arrange and coordinate calibrations by external Calibration Services providers to maintain 100% compliance to schedule with no past-due calibrations * Maintain the calibration software, including an up-to-date listing of applicable equipment and its associated historical records * Other duties as assigned
Ideal Candidate
**Education and/or Experience:** * BS in Engineering or similar discipline, preferably Electrical or Mechanical Engineering. Will accept significant technical background / experience as a substitute for an Engineering degree. * 3 to 5 years of Quality Assurance experience, preferably in a medical device manufacturing environment or other regulated industry. * Experience in successfully working within ISO/FDA compliant Quality Management Systems and supplier quality programs. **Preferred Requirements :** * Experience with statistical software packages (preferably Minitab), as well as Microsoft Office. Working knowledge of Process Controls and Design Controls within a regulated Quality Management System (CFR 820), and applicable knowledge of Risk Management and Supplier Quality is required. * Experience with root cause analysis, DOE, statistics, lean manufacturing, trending, Risk Management, and Six Sigma methodologies. * Past experience in Operations highly desired. * Familiarity with electrical medical device manufacturing and the Toyota production business model helpful, but not required. **Personal Trait Profile:** * Self-sufficient * Enthusiastic * Team orientation (knows when to lead and when to follow) * Lives the “continuous improvement” philosophy and can drive change successfully * Logical and creative thinker * Confident * Ability to influence others – credible * Ability to articulate the DBS philosophy * Facilitation skills

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