Title: Sr Quality Engineer
Pay: 45.00-$52.00/hour
Location: Draper, UT
Schedule: Standard Office Hours
Duration: 2-year contract
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:
In this role, you will manage and support a variety of projects within the Quality/Manufacturing Engineering department. Key responsibilities include:
- 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
- Proven expertise in statistical techniques
- 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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