Experience Requirements
The Quality Engineer will be responsible for working as a part of a team, which ensures that all internal/external manufacturing projects meet all Quality system requirements. Perform engineering work requiring application of design of experiments, statistical techniques, Risk Management. Applies engineering practices and techniques to specific situations, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps or processes.
Qualification Requirements
Requirements Quality System Regulations knowledge (QSR 21 CFR part 820, ISO 14971, ISO 13485) Medical Device Design Control knowledge and experience (IEC/UL 60601, MDD, CMDCAS) Knowledge / Education. B.S. Degree, (Mechanical/ Electrical) preferred Strong skill level in engineering principles (design of experiments, statistical data analysis, tolerance analysis, risk management, human factor engineering, FMEA/FTA, reliability, validation, development and execution of protocols/reports.
Preferred Qualifications
Skills / Competencies Strong skill level on MS Word, Excel, Access, Power Point, Visio Experience with Solidworks, CAD Excellent verbal & written communication skills including presentations (internal & external customers). Proven ability to interact successfully with all levels of the organization. Must possess high degree of organizational skills and be a self-starter Ability to work in and contribute to a product development team and other team environments. Ability to plan and prioritize activities Ability to work independently to meet assigned project deadlines
Responsibilities
Work with Management and team developing/ improving programs to ensure improved quality and reliability in products, and reduce the total cost of Quality including: Reliability studies. Customer complaints. Customer returns. Field service & repairs. Represent Quality Assurance through all product design and development life cycle phases to help ensure product manufacturability, reliability and cost effectiveness. Responsible for writing and reviewing Non-Conformance Materials Review to verify discrepancy and adequacy of response to corrective action request. Create documentation associated with engineering activities including: Quality Plans. Verification & validation protocols/ reports. Update/ rewrite Quality System/ Department procedures. Participate in product complaint investigations, root-cause analysis, and corrective and preventive actions. Key contributor in Corrective Action and Preventive Action (CAPA) System. Perform Quality System/ Process Audits. Responsible for Supplier Quality system in monitoring and auditing.
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