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medmix · 3 weeks ago

Senior Quality Systems Engineer - Healthcare

Flowery Branch, GA

Full-time

Onsite

Senior Level

$96K/yr - $106K/yr

medmix is a global leader in high-precision delivery devices, focused on innovation and quality within the healthcare sector. As a Senior Quality Systems Engineer, you will develop and execute compliant quality systems and manage the quality management system to ensure adherence to established standards and regulations.

Health CareManufacturingMedicalMedical Device

Responsibilities

You will manage day to day maintenance of the quality management system but also develop quality programs that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines

Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance

Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations

Lead audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits

Lead internal quality improvement activities within a quality plan

Manage, prepare and report CAPA quality system to provide status and metrics to applicable stakeholders, both internal and external

Drive root cause investigations, provide compliant options for resolving lab technical and quality issues (lab investigation reports), in compliance with QMS and regulatory expectations

Aid in Management Review preparation

Analyze, trend, and report data supporting the quality system (KPI’s)

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

Qualification

ISO 1348521 CFR 820CGMP standardsQuality management systemValidation experienceRoot cause investigationsQuality AgreementsCommunication skills

Required

Bachelor's degree in Industrial Engineering, medical technology or a related field

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

Required experience with good documentation practices and cGMP standards

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

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

Thorough understanding of ISO 14971 from implementation through device lifecycle

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