Sr. Design Quality Enginr

A Day in the Life

• Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Capable of mentoring junior quality engineers in providing quality engineering support.

Must Have

• Review New Product Introduction (NPI) and Released Product Management (Released Products) documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Familiar with ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
• Ensure that product development projects and changes to existing products are conducted in compliance with IEC 62304, FDA Quality System Regulations, EU MDR and inhouse Standards.
• Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
• Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
• Hanson experience in SW anomaly evaluation and disposition, complaint investigation, NC/CAPA
• Ensure successful transfer of new products to production facility by assisting in development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
• Strong in software design and development, software verification and validation activities
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Participate when appropriate in audits
• Demonstrates mastery of software development and testing methodologies
• Independently develops test strategies for new, pre-concept features in development.
• Ensures applicability to SOUP / OTS validations in the product development
• Participates on CCB to decide upon CR implementation.
• Assesses the compliance of the software development methodology to the approved process.
• Participate and provide input to training on department / procedures and policies
• Hands-on experience on Software Risk Management, Design Controls.
• Facilitates hazard analysis and SFMEA sessions. Prepares the risk management file.
• Acts as the subject matter expert on risk management for one or more products/platforms.
• Applies quality system regulations, applicable standards and guidance to multiple projects
• Develop templates and training based on the quality system regulations, applicable standards and guidance.
• Independently reviews all SW deliverables to ensure compliance with development process and the standard.
• Deliver presentations to the QA organization on status and issues of assigned projects. Deliver training to departments outside of QA.
• Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.
• Previous experience working in a cross-functional team environment.
• Provide Quality support to facilitate resolution of product complaints and/or safety issues
• Provide support to the Regulatory Department in writing technical submissions.

Minimum Qualification

• B E or B.Tech
• Minimum 6-8 years of quality engineering experience or equivalence and overall 8-13 years of experience

Key Technical Competencies

• Previous experience working in a cross-functional team environment.
• Familiar with statistical software tools (Minitab, Stat Graphics)
• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
• Strong in software design and development, software verification and validation activities
• Computer literate and experience with PCs, networks, applications, software development life cycle
• Travel may be required
• Knowledge in cybersecurity

Nice to Haves

• ASQ CQE, CQA, CSQE and/or CRE certification.
• ISO 13485 Internal Auditor / Lead Auditor Certification
• Lean Six Sigma Green Belt or Black Belt
• Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.
• Familiar with DMAIC or DMADV(DFSS) methodologies