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Principal Quality Engineer - M...
For a detailed job description including salary information please reference Job Number 2027 on http://www.coyotesourcing.com/board.html .
Job Title: Principal Quality Engineer:
Job Summary: The Principal Quality Engineer is responsible for supporting all quality engineering activities to support the product life cycle, from development of new products (NPD) from concept through commercialization, through sustaining changes, as part of a cross-functional development team. This includes active participation in origination of design concepts, design specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, project planning, and applicable documentation. Responsible for all aspects (product and process) related to the quality of the designated product line(s). This includes manufacturability of products, supplier manufacturing, and investigation of customer complaints. Develops, modifies, applies and maintains quality standards, and generates protocols and reports. The Principal QE provides coaching to Design Engineers and Manufacturing personnel on Quality System Requirements and process improvement methodologies for their product families.
: 7 -9 years work experience in a Quality Engineering role, in the implantable medical device industry, with a history of successful participation in New Product Development (NPD) teams.
: Strong working knowledge of Design Controls, manufacturing process controls
: Understanding of human factors engineering
: Proficient in GD&T and metrology. Able to read detailed blueprints and follow assembly instructions, develop inspection plans and evaluate CMM programs. Gage R&R preferred.
: Ability to use metrology and statistical methods to diagnose and correct improper quality control practices, with experience in CMM Programming, GD&T, Gage R&R and Inspection Plan development
: Demonstrated successful application of analytical quality tools including Six Sigma, Lean, SPC. DFSS training preferred
: Computer literate in various software applications. (i.e. -Word, Excel, Access, Minitab.) Solidworks experience preferred
: Independent organization and prioritization of multiple tasks
: Able to lead DFMEA and PFMEA sessions as required
: Communication: Ability to internally and externally discuss and clearly define key technical and process development issues and independently develop course of action/plans
: Strong technical writing skills and ability to create technical protocols and reports as well as manufacturing/inspection procedures
: Interpersonal: Ability to cooperate and support team members and ability to coordinate interdepartmental activities and to resolve individual conflicts and issues.
: Business Acumen: Require a basic understanding of business and financial impact of project.
: Teamwork: Pursue trust for each team member. Seek and deliver honest feedback to all team members. Committed and accountable to achieving team goals. Abide by team decisions
Required Education and Licensing/Certification requirements:
: Bachelor of Science (B.S.) degree in Biomedical or Mechanical Engineering with a minimum of nine (9) years of experience in the medical device industry, or
: MS degree in Biomedical or Mechanical Engineering with a minimum of seven (7) years of experience in the medical device industry.
: Experience in Lean, Six Sigma and Process Validation/Process Capability
: ASQ CQE/CSSBB or equivalent preferred
No sponsorship visa (H1-B, etc) candidates at this time, sorry.
Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:
COYOTE TECHNICAL & EXECUTIVE SOURCING
Director of Sourcing
220 Miracle Mile, Suite B219
Coral Gables, FL 33134
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