The Quality Engineer Manager – Product Development will be responsible for assisting with the development and improvement of a Design Controls Quality System process that is compliant with ISO 13485 and FDA Quality System Regulation 21CFR Part 820 requirements. They will be a key participant on design/development project teams by providing support and guidance on current and new product development involving the creation of validation plans/protocols, risk management program and engineering change controls. In addition, the Quality Engineering Manager must be able to interact at a working level with the following business pillars: Marketing, Project Management, Project Development Teams, R&D, Software Development, Manufacturing Operations and Customer Support.
Lead Product Development Team in the planning and execution of design and development deliverables including: Customer Requirements, Design Input Requirements,
Design and Development Planning, Risk Management, Requirements Traceability
Management, Product/Material Specifications, Design Transfer, Verification and Validation and Design Reviews activities.
Review and approve product releases to verify quality requirements are defined.
Participate in resolving design controls and manufacturing quality-related issues.
Assess, create and implement new methods, techniques and evaluation criteria for identifying and mitigating risks, and implementing corrective actions.
Assist in Internal Audits and External Audits in support of the Quality System
Create new documents or edits existing documents in support of the Quality System.
Edit and ensure the production of well written test protocols and reports
Interact with subordinates, peers and various management levels across departments to ensure quality compliance.
BS/BA degree in life science or related field or equivalent combination of education and work experience.
Minimum of 8+ years of experience of progressive responsibility and experience in
Quality Engineering in a medical device or in vitro diagnostic device manufacturing environment.
Prior experience in developing, implementing and improving a Quality Management System.
Demonstrated proficiency utilizing problem solving tools (i.e. FMEA, SPC, etc.).
Proven experience in Quality Systems with an emphasis on ISO 13485 and 21CFR Part 820.
Knowledge of Statistical Analysis tools.
Trouble shooting capabilities leading to root cause.
Ability to manage multiple priorities in a fast paced and dynamic environment.
State or Province