Senior Quality Engineer

Job Description Summary:
• Hands-on Quality Engineer at electronic medical device contract manufacturer.
• Responsible for broad-based quality assurance activities in the design and development, manufacturing, and post-market surveillance of electrical medical devices including active participation in product development (leading planning, requirements, verification, validation, process validation and risk management activities); active participation in manufacturing quality issues (spearhead incoming and in-process NCMRs, Rework, MPI/LHR/DMR updates, production process improvements, Process FMEA, Process Validation/MVP, other production issues/needs) and active role in post-market surveillance (spearheading RMAs, Complaints, CAPAs, Customer Feedback, other activities).
• Responsible for general QMS maintenance including: Document Change Orders, Management Responsibility, Training, Equipment Management, Supplier Management, Internal and External (Customer, Regulatory, Notified Body) Audits.
• All activities are conducted in compliance with FDA QSR, ISO 13485, MDD regulations as well as internal quality system documents
Position Responsibilities and Authorities:
• Work proactively to develop and implement effective and beneficial quality system strategies that maintain compliance with regulations, standards and EMS QMS and ensure efficiency.
• Lead regulatory inspections and audits.
• Establish and maintain quality management system processes and documents. Make updates as necessary to ensure compliance and overall efficiency.
• Participate, coordinate, and conduct internal audits and supplier audits.
• Develop and review procedures to ensure that the appropriate checks and balances are included to ensure quality and provide for efficiency.
• Support the Document Control and Record retention program.
• Lead Management review process.
• Manages and maintain Quality Management processes: Material Authorizations, Complaints, Feedback, CAPAs, NCMRs, Deviations, etc.
• Root Cause Analysis for Quality Management processes: Complaints, Feedback, CAPAs, NCMRs, Deviations, etc.
• Lead the design and development efforts for EMS design projects. Coordinate with EMS’ clients on product development.
• Develop, review, and approve design input and design output requirements.
• Lead in preparation and approval of risk management documentation.
• Develops, review, and approve verification and validation protocols.
• Assist in design transfer of medical devices from engineering to manufacturing.
• Assist in preparation of Design History Files and supporting documentation.
• Lead design reviews.
Job Description
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• Develop, review, and approve manufacturing documents.
• Develop, review, and approve device master record documents.
• Develop, review, and approve equipment qualification and process validation protocols and reports.
• Other duties as assigned.
Qualification Requirements:
Education:
• Bachelor’s Degree in engineering emphasis.
Experience & Skills:
• Familiarity with electrical medical systems (Software, Hardware, general devices).
• Minimum of 7 years of experience in medical device quality assurance.
• Dynamic leadership and interpersonal skills.
• Working knowledge/familiarity with USA FDA QSR, ISO 13485, MDD/MDR requirements.
• Effective / Excellent verbal and written communications.
• Experience developing and implementing quality systems.
• Works well under pressure, organized and self-motivated.
• Problem solving and analytical abilities to help EMS navigate issues across the QMS.
• Able to make decisions that maintain compliance within the QMS and provide for solutions that are effective and beneficial to EMS.