39 applicants

Company

Original Job Post

medmix · 3 days ago

Senior Quality Engineer

Flowery Branch, GA

Full-time

Onsite

Senior Level

7+ years exp

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Responsibilities

Provide Quality oversight to ensure quality processes are in place for the qualification of lab equipment and fixtures prior to use for GxP activity.

Responsible to ensure device testing, method development, method transfers and troubleshooting and all related documentation is compliant to applicable regulations.

Identify and control Manufacturing process defects by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.

Actively participate in test method development, and transfer meetings to ensure compliance with procedures.

Support the development of Plans for development, verification/validation, technology transfer, and risk management in line with applicable regulations for medical device products.

Provide Quality oversight for the development, review, and approval of key Design History File deliverables including Verification and Validation Protocols and Reports, Risk Management deliverables, and Transfer Plans.

Support root cause investigations, provide compliant options for resolving lab technical and quality issues, in compliance with QMS and regulatory expectations.

Review and approve complaint investigation and root cause, CAPAs.

Analyze, trend, and report data supporting the quality system.

Draft, review, and approve Quality Agreements (QAG) for equipment vendors, method developers, and service providers.

Qualification

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ISO 1348521 CFR 820 documentation practicesCGMP standardsISO 14971Personal computersWord processingSpreadsheetsPresentation softwareDatabase softwareClean room environmentProcess validationEquipment validationProject managementProblem-solvingCommunicationOrganizationIndependenceMotivationTeamworkInjection moldingSOPsCGMPsRegulatory guidelinesCompliance management

Required

7+ years of validation experience in a regulated manufacturing environment related to quality control of medical devices per ISO 13485 and 21 CFR 820.

BS degree in engineering field

Experience with good documentation practices and cGMP standards.

Thorough understanding of ISO 14971 from implementation through device lifecycle.

Proficiency in the use of personal computers, especially word processing software, spreadsheets, presentation, and database software.

Experience working in a clean room environment and performing process and equipment validations.

Ability to perform work accurately and thoroughly and to work independently with minimal supervision.

Must be organized and able to follow a systematic method of performing tasks and the ability to organize and direct a project to completion.

Must be self-directed and motivated to optimally utilize the available time to organize and complete expected work within given deadlines and reasonable work schedules.

Communication skills, both oral and written, as required to communicate effectively with others at all levels in the organization and to provide clear and concise reports and policies as needed. Ability to effectively present information publicly.

Ability to work well with subordinates, peers and superiors in all departments.

Preferred

Experience with injection molding processes, parameters, and troubleshooting is preferred.

Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.