Our mid-sized medical device client is adding a Design Assurance (DA) Manager to the team. The DA Manager will be responsible for providing quality engineering support for all phases of product development, driving post-market assessment activities, and supporting consistent design through production release and commercialization.
Your role with the company :
Responsible for ensuring staffing and successful execution for all projects assigned to the DA team. Serve as a working team member in the execution of product development process (PDP) deliverables for complex projects. The DA manager will own development / improvements for procedures in the areas of Design Control and Risk Management and serve as a corporate-wide SME, major contributor and key influencer on Design Controls, Risk Management and Post Market Surveillance activities.
Management
Develops and maintains a solid team environment through effective hiring, communication, recognition, feedback and development
- Working manager that both manages the team and serves a design assurance function for assigned teams or projects
- Monitors, directs, and prioritizes staff workload to ensure business objectives are met
- Contributes to establishing overall Quality department yearly goals and objectives
- Advises planning for department resource needs
- Responsible as primary interface for internal audits, regulatory body audits for responsible areas
- Determine appropriate staff levels and schedules while working with key partners to understand priorities and plan resource allocation accordingly
- Provides mentoring and coaching for less experienced staff
Product Development Team Member
Serve as DA Lead (Core Team member) on cross-functional PDP teamProvide subject matter expertise and leadership in the area of Design Controls and Risk ManagementUnderstand clinical application of the product, utilizes clinical knowledge while supporting development of design inputs and clinically relevant test methodologiesLead execution of risk management activities for PDP projectsDevelop Design Verification, Design Validation, and Usability plans, protocols and reportsDevelop and execute or oversee test method validationsPlan post market activities for the project through development of PMS Plan, Field Assessment Plan and support of Clinical Evaluation, clinical literature review and PMCF studiesUnderstand regulatory requirements for the product, supports pre-submissions, submissions, and questions from the regulatory agencies.Lead problem solving activities, failure investigations, and CAPA activitiesSupport design transfer activities including process validation and material qualifications.Serve as project manager for the project or specific area of the project, if requested.Provide subject matter expertise for assigned projects in auditsBalance complex performance, regulatory, and manufacturing requirements to achieve most optimal solution for the project.Post Market
Lead planning and facilitate execution of post market surveillance activitiesLead complaint investigations in the categories of risk assessment investigationsGenerate Field Assessment and Post Market Surveillance reportsAnalyze engineering change requestsSupport process and design change activitiesAddress regulatory standards gap assessments to maintain product complianceQuality Systems
Drive improvements to the design control, post-market surveillance, risk management, and any other assigned processes to ensure ongoing complianceDevelop and maintain key quality metrics and drive improvementsDevelop risk-based procedures and instructions throughout the quality systemPresent trending data to management during management reviewReview current regulations and requirements and recommend changes to quality systemProvide Quality Representation for NCMR, Complaints, internal and external audit findings and CAPAsDesired Profile :
BS or advanced degree in technical discipline, engineering preferred3+ years management experience8+ years overall medical device experience8+ years' experience in DA or Quality Engineering functionExtensive experience with QSR and ISO regulationsExtensive experience with statistical techniques, measurement / trending and SPC toolsDemonstrated technical expertise and leadership in QualityStrong emotional intelligence to work effectively in a fast-paced, highly-collaborative environmentSelf-starter, with the ability to manage multiple tasks and tight timelinesDemonstrated use of tools and methodologies within a Quality SystemProficient computer skills- Microsoft Word, Access and Excel, statistic software (jmp, minitab)