SUMMARY
The Staff Quality Engineer is responsible for providing quality engineering direction to projects, such as risk management, design concepts, design specifications, design for quality and manufacturing requirements, process/technology development, design and process validation, measurement systems analysis, equipment and software validation, project planning, and associated documentation. This position will play an active role in development the quality management system and ensure QMS compliance adherence.
PRINCIPAL DUTIES AND RESPONSIBILITIES
2.1 Develop, establish, and maintain QA processes, procedures, and controls ensuring that performance and quality of products conform to established standards and regulations.
2.2 Work with R&D, Manufacturing Engineering, Regulatory, and Clinical team to develop and execute Quality Engineering activities to meet project milestones.
2.3 Provide guidance and oversee the documentation process (Design History File, Device History Records and Device Master Records).
2.4 Participate in designing and drafting plans/protocols for testing of complex medical device products with the Quality and R&D team.
2.5 Lead Risk Management efforts in accordance with ISO 14971 and Design Control efforts in accordance with ISO 13485 and 21CFR 820.
2.6 Participate on Corrective and Preventive Action teams in response to concerns identified through complaints, nonconforming materials or other trending activities.
2.7 Qualify new suppliers, maintain the Approved Supplier List (ASL), and manage the Supplier Corrective Action Request (SCAR) program.
2.8 Participate in Quality Assurance audits from 3rd party agencies, ensure timely and effective resolution of issues identified
2.9 Maintain quality system in compliance with all applicable regulatory standards (FDA QMSR, ISO 13485, MDR requirements) and other relevant requirements throughout the facility
2.10 Identify and implement changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using: quality policy, quality objectives, audit results, analysis of data, etc.
2.11 Other duties as assigned
EXPERIENCE REQUIREMENTS
3.1 Minimum 5 years relevant experience in the medical device industry.
3.2 Experience in Quality System requirements, such as Design Control, Risk Management, Quality, Production Process Controls, Supplier Controls, Corrective and Preventive Action, Non-Conformance, Complaint Management, and Post Market Surveillance.
EDUCATION REQUIREMENTS
4.1 Bachelor's Degree in Life Sciences, Engineering, or equivalent is preferred.
4.2 Biomedical or Quality Auditor certification desired.
OTHER QUALIFICATIONS
5.1 Proven knowledge of ISO 13485, 21 CFR 820, MDD/MDR regulations.
5.2 Training and application of ISO 14971, application of risk management to medical devices
5.3 Excellent written and verbal communication, and time management skills required.
5.4 Demonstrated ability to communicate complex topics with a variety of audiences, including technical teams, management, auditors, and non-experts in a clear and effective manner.
5.5 Must have a positive attitude with excellent communication, negotiation, and interpersonal skills to maintain a team-oriented environment and develop critical relationships with internal and external stakeholders.