Senior Quality Engineer

TalentBurst•Draper, UT

4d•Onsite

About The Position

The Senior Quality Engineer will lead identification, development, and optimization of Manufacturing processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for continuous process improvement initiatives. This role involves identifying opportunities and implementing solutions for re-design/design of equipment, tools, fixtures, etc., to improve manufacturing processes and reduce overall process/product risk profile. The position requires monitoring Critical Control Points and driving the development and execution of experiments and tests to improve products and establish robust manufacturing processes/test methods. Collaboration with cross-functional teams, engineers, and technicians is essential for project success and on-time completion. The role also includes developing training and documentation materials, sustaining technical content of risk management files, leading investigations of complex manufacturing product quality and compliance issues, and overseeing quality support tasks.

Requirements

Proven expertise in usage of MS Office Suite
Ability to read and interpret drawings
Proven expertise in statistical techniques
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
Ability to translate technical information to all levels of the organizations
Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
Knowledge of Six Sigma concepts with ability to apply to work product
Knowledge of Quality Engineering concepts with ability to apply to work product
Problem-solving, organizational, analytical and critical thinking skills
Understanding of processes and equipment used in assigned work
Strong leadership skills and ability to influence change
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Work is performed independently
Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts

Nice To Haves

ASQ Certified Quality Engineer (CQE)
Six Sigma Green Belt or better
Experience with automation, software testing, and software validation is strongly preferred

Responsibilities

Lead identification, development, and optimization of Manufacturing processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for continuous process improvement initiatives.
Identify opportunities & implement solutions for re-design/design of equipment, tools, fixtures, etc., to improve manufacturing processes and reduce overall process/product risk profile.
Monitor Critical Control Points.
Drive the development and manage the execution of experiments and tests (including writing and executing protocols) to improve products (including evaluation of source materials and suppliers) and establish robust manufacturing processes/test methods based on engineering principles; ensure completion of process validations (TMV/IQ/OQ/PQ), including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion.
Collaborate with engineers for equipment selection and validation.
Develop training and documentation materials for production and Receiving Inspection (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
Develop and sustain technical content of risk management files.
Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., Material Review Board, NCR, SCAR, CAPA, non-conformances, audit observations) for all production processes and based on engineering principles; analyze results, make recommendations and develop reports.
Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and operators and provides feedback; and may coordinate engineers/ technician work.
Lead, review and approve compliant change control.