Senior Quality Systems Engineer - Healthcare

medmix•Flowery Branch, GA

About The Position

As Senior Quality Systems Engineer - Healthcare you will be responsible for supporting the Healthcare business by developing and executing a compliant ISO 13485/21 CFR 820 and 21 CFR 210/211 quality system. 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

Requirements

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

Nice To Haves

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

Responsibilities

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