medmix · 2 days ago

Senior Quality System Engineer

Flowery Branch, GA

Full-time

Onsite

Senior Level

3+ years exp

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Health CareManufacturing

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Responsibilities

Lead a team to manage day-to-day maintenance of the quality management system and develop quality programs for compliance.

Provide expertise in interpreting policies, regulations, and internal guidelines to ensure compliance.

Prepare reports, documentation, and corrective actions for stakeholders.

Oversee complaint, nonconformance, CAPA, document management, and records systems.

Drive root cause investigations and provide compliant options for resolving quality issues.

Review and approve complaint investigations, root cause analyses, and CAPAs.

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

Draft, review, and approve Quality Agreements for vendors and service providers.

Qualification

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ISO 1348521 CFR 820 documentation practicesCGMP standardsISO 14971PC proficiencyClean room environmentProcess validationEquipment validationProject managementCommunicationOrganizationProblem-solvingIndependenceMotivationTeamworkInjection MoldingProcess ParametersTroubleshooting

Required

3-5 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

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.