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Senior Quality Engineer
3 months ago
Top Needs:
- design controls
- process validation
- Risk Management
- Statistics
- 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.
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 company 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.
