Senior Quality Systems Engineer - Healthcare

medmix • Flowery Branch, GA

4d

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 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

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

• Manage day to day maintenance of the quality management system
• 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

Benefits

• An innovative, vibrant and agile culture
• Growth opportunities in a globally successful and dynamic business on a growth trajectory
• Excellent employee benefits including: Medical, dental, vision, Life/AD&D, Short- and Long-Term Disability
• Employee Savings Plan / 401k with 100% employer match

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees