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Senior Quality Engineer
4 months ago
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.
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 controls
process validation
Risk Management
Statistics
Test 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 controls
2. process validation
3. Risk Management
4. Statistics
5. 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.
