Sr Quality Engineer
2 months ago
Job Description:
A Day in the Life ·Participating in complex medical device product development per the FDA design controls starting from design planning through design transfer by demonstrating a firm understanding of the design input, risk management, design verification, design validation and design output/transfer processes & tools as applied to product development.·Collaborate with cross-functional teams and apply a systems mindset to develop and evaluate designs from a design input requirements / design outputs perspective that span across multiple product interfaces.·Drive risk management deliverables by facilitating and generating design and process failure modes effects analysis (DFMEA/SWFMEA/PFMEA) and Hazard Analysis and experienced in facilitation / execution of the process or design/software FMEAs.·Utilize the risk management and robust design principles to develop and identify essential design outputs / critical to quality (CTQ) attributes by partnering with appropriate design team members in early design and development.·Design Verification/Validation and Reliability demonstration – Understands and applies basic Design Verification/Validation methods & principles for developing design verification, validation, and reliability test strategies. Participates and collaborates with test engineers in the development, modification and design review of Protocols, Data Summaries & Record.·Collaborating with the various product development teams like R&D, Ops, Design / Supplier quality, risk management etc to ensure work products comply with Client procedures, acceptable qualitative and quantitative criteria, and global standards and regulations.·Collaborating with Ops in reviewing and approving Assembly Procedures, Travelers, and Work-Orders.·Generating master validation plans/reports and design transfer activities as applicable.·Partner with cross-functional teams in performing Process Qualification activities.·Assisting Supplier Quality engineering and purchasing teams in vendor development and component engineering qualification activities (PPAP activities).·Effectively navigates & facilitates project teams with respect to internal processes and procedures ensuring the delivery of safe and effective products.·Driving clarity and consistency in documentation.·Review and Close out Non-Conformances (NCs) as they occur.·Leading CAPA projects and assisting post market analysis.·Participating in support of external and internal regulatory audits and inspections.·Driving Process improvement activities.·Work under consultative direction toward predetermined long-range goals and objectives Assignments are often self-initiated Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.·Performs other related duties as assigned.
Requirement:
Must Have• Bachelor’s Degree in Engineering or Science with 4+ years of work experience in Quality and/or Engineering OR Master’s Degree in Engineering or Science with 2+ years of work experience in Quality and/or Engineering.design controlsprocess validationRisk ManagementStatisticsTest Method Validation Nice To Have• Experience working in a regulated industry (e.g., FDA-regulated) • Bachelor’s Degree in Biomedical, Mechanical, Chemical or Electrical preferred • Master’s Degree in Engineering, Quality, Regulatory, or related • ASQ Certification in Quality or Reliability • Strong understanding and hands on experience with the FDA production and process controls (P&;PC), experience in planning of process validation / test method validation activities• Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization • Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable • Self-Starter with a sharp focus on quality and customer experience. HM's Top Needs:1.design controls2.process validation3.Risk Management4.Statistics5.Test Method Validation Years’ Experience Required: Bachelor’s Degree in Engineering or Science with 4+ years of work experience in Quality and/or Engineering OR Master’s Degree in Engineering or Science with 2+ years of work experience in Quality and/or Engineering. Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience May have practical knowledge of project management Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
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