Principal Quality Engineer

Job type:
Real Staffing
San Jose
flag_no USA
project ID:

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* Support the development and manufacturing of medical devices in conformance with the Quality System Regulation, ISO 13485, Medical Device Directive, ISO 14971, IEC 60601 and other regulatory standards
* Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control
* Contribute to the streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative healthcare products
* Provide guidance for the application of internal development procedures, including Design Control, to the product development teams, within the framework of regulatory requirements
* Provide guidance and interpretation for industry related regulations within the framework of product and sustaining development processes
* Interact and form constructive working relationships with all levels of leadership within Quality, Procurement, Marketing, R&D, and Operations
* Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized
* Act as a core team project resource providing leadership in developing/identifying/performing:
* Quality Plans (product and supplier)
* QFD's
* Risk Management Plans and Reports
* Risk Assessments including Hazard Analyses and Risk Analyses
* Fault Tree Analysis/FMEA's (Design, Application, and Process)
* Design Verification and Validation strategies and acceptance criteria
* Test method development and validation
* Risk based sampling plans
* First Article Inspection's and Reports
* Process Capability Analyses
* Post Market Surveillance Reports
* Ensure completeness of project documentation (e.g., DHF)
* Provide engineering expertise and support in supplier and internal auditing, external lab qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination
* Collaborate with plant QA and/or lead Quality Engineering initiatives for the Covidien manufacturing facilities associated with NPD projects, ensuring quality deliverables have been met
* Coordinate and lead design quality related product complaints investigations
* Ensure all tasks are conducted in accordance with applicable regulatory standards and standard operating procedures


* Bachelor's in Engineering or associated scientific discipline or equivalent work experience; Graduate degree preferred
* 8+ years medical devices experience in Quality or R&D Engineering position
* DFSS or DMAIC Black Belt Certified
* Certified Quality Engineer (CQE)
* Certified Quality Auditor (CQA)
* Proficient with Minitab
* Coaching and mentoring skills
* Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
* Proven ability to directly lead and/or co-lead multiple tasks and projects
* Strong understanding of industry expectations in the areas such as voice of customer, specification development, risk management, design verification and validation, stability studies, sterilization validation, biocompatibility, transportation testing, etc.
* Working knowledge of quality engineering principles, supplier management, and manufacturing operations within a regulated industry (preferably medical devices)
* Proficient with utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.)
* Working knowledge of electro-mechanical devices, software validation methods, and/or plastics related manufacturing processes (i.e. extrusion, injection molding, RF welding, etc.) is preferred
* Ability to interpret mechanical drawings
* Familiar with gage and inspection techniques
* Strong collaboration, negotiating, and conflict resolution skills
* Fluid verbal and written communication skills
* No medical conditions preventing access to a controlled environment room
* Office is located in San Jose, CA

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