Job Title - Sr Quality Engineer -Medical Device
Job Location -Northridge, California.
Duration:-12 Months
Job Description -
HM's Top Needs:
· Design controls
· process validation
· Risk Management
· Statistics
· Test Method Validation
Responsibilities:
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 with 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.
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
