Sr. Quality Engineer, Design Quality - Scottsdale, United States - IntePros Consulting

Description

IntePros is currently looking for a Sr. Quality Engineer, Design Quality to join one of our premier Medical Device Manufacturers in Scottsdale, AZ. The Senior Quality Engineer, Design Quality provides quality leadership, governance, and engineering best practices to medical device, combination product, and containment product development programs. This is a global role that will oversee multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the development lifecycle into manufacturing and sustainment. The incumbent will provide quality leadership for development projects from product inception through design transfer including partnering with Operations to establish and qualify / validate the manufacturing process as part of NPI. This role will ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements according to the intended distributed markets.

They will partner with R&D, Regulatory, Supplier Quality, and Operations to establish consistency across product platforms, drive engineering design improvements, and lead implementation of design control related strategies and objectives. This role will drive harmonization and alignment of client design control methodologies and processes across product platforms, sites, and teams to ensure consistency and state-of-the-art Design History Files.

The incumbent will be a strong advocate for product, process, and system quality at all stages of product realization. Additionally, this role will identify and implement improvements within the Global Enterprise Quality Management System as part of continual improvement and global objectives.

Senior Quality Engineer, Design Quality Responsibilities:

• Exhibit a strong "quality first" mentality and ensure that product and process quality are held to the highest standard.
• Provide Quality Engineering oversight and direction for multiple concurrent product development programs to ensure product & process compliance to all applicable regulatory and cGMP requirements.
• Provide leadership on the product development process, process validation/qualification, and compilation of design related technical and engineering product and process documentation. Partner with R&D teams to implement strategic platform product development approaches to product development.
• Author, review, and/or approve DHF documentation (e.g., strategic planning, product specifications, design verification & validation activities, risk management activities, test method validations, protocols, reports, product transfer to operations, etc.)
• Provide quality oversight, review, and approval of qualification documentation and reports. Provide direction during technical and design review activities as a Design Quality SME. Provide Quality oversight of qualification/validation/design controls activities to other QEs. Review the quality of work completed with the project team to ensure it meets project standards.
• Lead the development and maintenance of product or process risk and hazard analysis in accordance with client policies and procedures.
• Ensure the applicable development phase requirements are sufficiently fulfilled and documented within the DHF before allowing the project to proceed within the development process. Escalate and prevent the progression of product development, including release of clinical product, if warranted.
• Partner with Operations and Operations Quality during design transfer to ensure product DMR and knowledge transfer is complete and effective.
• Represent client Quality as the primary interfacing Design Quality SME with customers to ensure strong partnerships are established and implement solutions for any identified Quality concerns
• Authors and/or reviews reports by collecting, analyzing, and summarizing data; implements corrective actions where necessary as determined by trended data analyses. Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
• Drive a harmonized design control program globally within the enterprise with the support of Design Quality leadership. Author and review product development related QMS procedures and work instructions. Proactively identify potential gaps and lead projects to resolve them.
• Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services and processes, including the client QMS.
• Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, etc. Provide leadership and direct input on any nonconformance, deviation, or excursion that may occur and drive to closure.
• Establish routine communication strategies for project tracking and prioritization
• Drive continuous quality improvement projects
• Must observe all good housekeeping practices
• Other duties as assigned

• Bachelor Degree in Engineering or Science required
• Minimum 5 years of experience in Medical Device Quality & Product Development Lifecycle
• Relevant work history and/or experience may be considered in lieu of degree and/or years of experience
• Experience with customer interface and meeting customer expectations
• Experience with Medical Device Design & Development, Verification / Validation Activities, Risk Management, Product Transfer, DHF Activities
• Must have an in-depth knowledge of validations in a Medical Device environment
• Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971
• Strong project management skills
• Excellent written, critical reading, and oral communication skills
• Must have effective problem solving and interpersonal skills
• Ability to work independently, multi-task and thrive in fast-paced environment
• Strong problem-solving skills including root cause failure analysis methods
• Proficient in statistical software, Windows OS, Microsoft Office: Word, Excel, Power Point, and Teams
• Be aware of all relevant SOPs as per Company policy as they relate to this role
• Able to comply with the company's safety policy at all times

• ASQ certification (CQE or CQA)
• Green or Black Belt certification
• Graduate degree
• Strong project management skills
• Previous experience with MasterControl, SAP, Share Point, Teamcenter
• Experience with ISO 60601, ISO 62366, ISO 11607 a plus

• Must be able to travel up to 10% of the time

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations
• Maintain high attention to detail, accuracy, and overall quality of work
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Effectively communicate and interface with various levels internally and with customers