Sr R&D Quality Engineer (MEDICAL DEVICE)

Overview

Job Description : Senior R&D Quality Engineer

Position : Senior R&D Quality Engineer

Location : Charlotte, NC

Work Location : FULLTIME ONSITE

Department : Quality / R&D

Reports to : Quality Assurance Manager

Company Overview : At Aptyx, a new name backed by 70 years of expertise, we bring together the aptitude and excellence of more than a dozen companies with decades of experience helping customers in the life sciences and other demanding industries solve complex manufacturing problems with confidence so they can create more good things in the world. We are committed to delivering high-quality products and services to our customers worldwide. We are seeking a talented Quality Technician to join our dynamic team and contribute to our mission of excellence and innovation.

Responsibilities

• Quality Management System : Responsible for following and advising improvements to the Aptyx quality management system, including all applicable SOPs.
• Quality Record Review : Perform detailed review of quality documentation such as device history records and incoming inspection reports to assure quality of materials, components, and medical devices as needed. Effectively train lower level QA staff to review records with a similar level of detail.
• Design History File Documentation Review : Perform detailed review and provide input to the creation of design history file (DHF) documentation such as user needs, engineering specifications, design verification test documentation, drawings, material specifications, and planning documents.
• Risk Management Support : Provide support as a team member and reviewer for risk management activities such as FMEA.
• Quality Activity Management : Support timely execution of quality activities such as CAPAs and NCRs as champion of the activities. Effectively delegate tasks to other team members.
• Data Analysis : Use data analysis and statistical techniques to plan sample sizes and analyze testing results for R&D testing such as Design Verification and Validation.
• Technical Support : Provide technical support to quality inspections, develop inspection process improvements, and training quality inspectors.
• Metrology Support : Provide metrology support for R&D projects by performing inspections using CMM, vision system, and other similar measurement equipment.
• R&D Build Support : Provide support for R&D builds by analyzing nonconforming conditions and providing feedback to quality inspectors as they work through inspections.
• Customer Support : Participate in meetings with customers to represent Aptyx project teams and provide input on quality-related topics. Influence the team to adopt a "quality first" mindset.
• Engineering Testing Support : Assist with design and validation (including gauge R&R) of engineering benchtop and inspection test methods supporting design verification, process validation, process verification, proof of concept, and lot release testing as required.
• Training and Development : Develop and deliver training for local quality inspection teams on R&D quality inspections to ensure that engineering requirements for devices are met and engineering's intentions are understood by inspectors. Train R&D engineers on requirements of the quality management system and other external requirements. Mentor junior R&D Quality engineers.
• Supplier Management : Communicate with suppliers to resolve quality issues, drive improvements, and support release of materials in a timely manner.
• Sterilization Support : Provide input to quality documentation surrounding routine sterilization of product and product-specific documentation related to validation of sterilization processes.
• Audit Support : Provide direct support for internal and external audits of Aptyx quality management system, facility, and design and development projects (occasionally as lead auditee as required by management).

Qualifications

Benefits

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