Sr Quality Engineer Job Draper area,Utah USA,Engineering

We are seeking a Quality Engineer to lead the identification, development, and optimization of manufacturing processes using engineering methods such as Six Sigma and Lean manufacturing tools. This role drives continuous process improvement, manages validation activities, and leads investigations into complex manufacturing quality and compliance issues within a clean room medical device manufacturing environment.

Job 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 and 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
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 seamless knowledge transfer of project and manufacturing processes
Develop and sustain technical content of risk management files
Lead investigations of complex manufacturing product quality and compliance issues (e.g., Material Review Board, NCR, SCAR, CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations, and develop reports
Oversee quality support tasks; give instruction to engineers/technicians on conducting tests; train engineers, technicians, and operators and provide feedback; may coordinate engineer/technician work
Lead, review, and approve compliant change control

Essential

Job Duties and

Job Functions:

Bachelor's Degree in a related Engineering/Science field (Materials Science, Mechanical Engineering, Chemistry) with 2+ years industry experience, or Master's Degree in a related Engineering/Science field with 1+ years industry experience
Bachelor's degree in engineering required, with 5-7 years of experience required

Knowledge and

Skills:

Proven expertise in usage of MS Office Suite
Ability to read and interpret drawings
Excellent documentation and communication skills and interpersonal relationship skills, including negotiating and relationship management
Ability to translate technical information to all levels of the organization
Extensive knowledge and understanding 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 Environmental Health and Safety and Quality guidelines as they relate to 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
Ability to work independently and in a team environment, including frequent inter‑organizational and outside customer contacts
Experience with automation, software testing, and software validation strongly preferred

Education and Experience:

Bachelor's Degree in a related Engineering/Science field (Materials Science, Mechanical Engineering, Chemistry) with 2+ years industry experience; or Master's Degree in a related field with 1+ years industry experience
Bachelor's degree in engineering required, with 5-7 years of experience required
Preferred: ASQ Certified Quality Engineer (CQE);
Six Sigma Green Belt or better

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