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We have an immediate need for a Quality Engineer with a medical device company in Kennesaw, GA. This is a direct hire opportunity with a salary and benefits.
- Serve as Customer Complaint Administrator. Initiate, document, investigate, test, implement corrective actions and submit complaint data to applicable regulatory authorities including FDA. Handle all aspects of complaint handling including complete complaint resolution/closure and auditing of closed complaint files for compliance.
- Evaluate, recommend, lead, develop, validate / verify and implement activities associated to product design quality, monitoring, qualification, validation and troubleshooting activities. This includes assessment of the effects on materials compatibility, manufacturing processing and product physical properties; change control, validation and verification; defect corrective action process.
- Review and perform final release of finished product Device History Record (DHR) files including finished device labeling and sterilization documentation for compliance to established specifications.
- Perform duties of Corrective Action – Preventative Action Administrator ensuring that CAPA Reports are initiated, assessed, investigated, properly documented, and completed such that safety and effectiveness of the product is supported.
- Perform RA/QA function of Installation Qualification (IQ), Operations Qualification (OQ), and Process Qualification (PQ) of new equipment and processes.
- Perform critical supplier audits for new and existing suppliers.
- Assist in preparation of management review reports.
- Provide statistical support to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification.
- Recommend, lead, develop, validate / verify and implement product/process improvements based on production and field input mechanisms.
- Troubleshoot and repair production equipment for resolution when in process tests indicate out of specification conditions.
- Serve as back up for the evaluation and inspection of incoming raw materials used in the manufacturing process.
- Assess in-process product and finished goods ensuring that each meet specifications.
- Serve as back up for Environmental Controls Administrator ensuring that clean-room / manufacturing areas are properly monitored to meet regulatory requirements and that out-of-specification results are properly corrected / prevented.
- Serve as back up for Material Review Board Administrator ensuring that Non-Conforming Material Reports are investigated, properly documented, and completed such that product is dispositioned appropriately.
- Participate in the product design process to assure new designs meet the quality requirements, meet safety, reliability and efficacy requirements, meet regulatory requirements.
- Perform duties of Change Control Administrator for manufacturing ensuring that process changes are executed in a controlled and planned manner.
- Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Quality Engineering or related field, or comparable experience working in the medical device industry, Quality Assurance, Regulatory Affairs, Compliance or Development.
- 3-5 years experience working in the medical device industry in the Quality Assurance, Regulatory Affairs, Compliance or Development departments.
- Must have an understanding of the FDA GMP Regulations (21 CFR Part 820), knowledge of Quality Tools/Sampling Plans/Problem Solving/Statistical Process Control/Design of Experiments, ISO 9001/ISO 13485, ISO 14971, FMEA, Reliability Planning and assessment of instruments, Product life cycle, design evaluation, and probability distributions.
- Ability to proactively manage and communicate status on multiple projects in a timely fashion as defined by the project plan and/or as established.
- Certification through the American Society for Quality (ASQ) as a Certified Quality Engineer (CQE) and/or as a Certified Quality Auditor (CQA) is preferred.
- Good technical writing, computer and interpersonal skills.
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