Quality Engineer
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Job Location:
Draper, UT - USA
Monthly Salary:
Not Disclosed
Posted on:
8 days ago
Vacancies:
1 Vacancy
Job Summary
Investigate moderately complex manufacturing product quality and compliance issues which may include:
- Investigate PRAs and complaints for manufacturing related issues
- Manage site NCRs CAPAs ECRs and audit observations for all production processes prior to final product release based on engineering principles; analyze results
- Provide technical support to external land internal audits
- Make recommendations and develop reports. 20%
Oversee product release assess and disposition product onhold (MRB) and manage material quality control.
Review and approve equipment validations and asset management actions. 15%
Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g. SIX Sigma TOPP and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment tools fixtures etc. to improve manufacturing processes and reduce risk 15%
Collaborate with engineering teams to ensure successful transfers 10%
May develop update and maintain technical content of risk management files review and revise pFMEAs in conjunction with BU PMS team where applicable for the plant site. 10%
Develop training and documentation materials for production (e.g. work instructions) to enable the seamless knowledge transfer of project and manufacturing processes 10%
Provides support to the following:
- Process validation or support/lead TMV
- Sustaining Quality Engineering responsibilities such as review Quality Metrics Material Review Boards Quality Control etc
- PMV Process Validation plans 10%
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. 5%
Solid understanding and knowledge of principles theories and concepts relevant to Engineering
Solid problem-solving organizational analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work
Develops solutions to a variety of problems of moderate scope and complexity
Contributes to process improvements
Work is performed independently and reviewed upon completion for soundness in technical judgment overall adequacy and accuracy
Participates in determining objectives of assignment; arranges own activities in accomplishing objectives
Contributes to the completion of more complex organizational projects and goals
Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources
Must be able to work in a team environment including the ability to manage vendors and project stakeholders
Ability to build productive internal/external working relationships
Bachelors Degree Engineering or Scientific field with 2 years related work experience Required or
Masters Degree or equivalent and internship senior projects or thesis in Engineering or Scientific field with including either industry or industry/education Required
Other: CQE (Certified Quality Engineer) if applicable Preferred
Good documentation communication and interpersonal relationship skills including negotiating and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required
Solid understanding and knowledge of principles theories and concepts relevant to Engineering
Solid problem-solving organizational analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work
Knowledge of and adherence to Quality systems
Education/Experience:
Bachelors degree in engineering required.
2-4 years experience required.
- Investigate PRAs and complaints for manufacturing related issues
- Manage site NCRs CAPAs ECRs and audit observations for all production processes prior to final product release based on engineering principles; analyze results
- Provide technical support to external land internal audits
- Make recommendations and develop reports. 20%
Oversee product release assess and disposition product onhold (MRB) and manage material quality control.
Review and approve equipment validations and asset management actions. 15%
Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g. SIX Sigma TOPP and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment tools fixtures etc. to improve manufacturing processes and reduce risk 15%
Collaborate with engineering teams to ensure successful transfers 10%
May develop update and maintain technical content of risk management files review and revise pFMEAs in conjunction with BU PMS team where applicable for the plant site. 10%
Develop training and documentation materials for production (e.g. work instructions) to enable the seamless knowledge transfer of project and manufacturing processes 10%
Provides support to the following:
- Process validation or support/lead TMV
- Sustaining Quality Engineering responsibilities such as review Quality Metrics Material Review Boards Quality Control etc
- PMV Process Validation plans 10%
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. 5%
Solid understanding and knowledge of principles theories and concepts relevant to Engineering
Solid problem-solving organizational analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work
Develops solutions to a variety of problems of moderate scope and complexity
Contributes to process improvements
Work is performed independently and reviewed upon completion for soundness in technical judgment overall adequacy and accuracy
Participates in determining objectives of assignment; arranges own activities in accomplishing objectives
Contributes to the completion of more complex organizational projects and goals
Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources
Must be able to work in a team environment including the ability to manage vendors and project stakeholders
Ability to build productive internal/external working relationships
Bachelors Degree Engineering or Scientific field with 2 years related work experience Required or
Masters Degree or equivalent and internship senior projects or thesis in Engineering or Scientific field with including either industry or industry/education Required
Other: CQE (Certified Quality Engineer) if applicable Preferred
Good documentation communication and interpersonal relationship skills including negotiating and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required
Solid understanding and knowledge of principles theories and concepts relevant to Engineering
Solid problem-solving organizational analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work
Knowledge of and adherence to Quality systems
Education/Experience:
Bachelors degree in engineering required.
2-4 years experience required.
