What are the responsibilities and job description for the Quality Engineer position at TekCommands Inc?
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
• Bachelor's Degree Engineering or Scientific field with 2 years related work experience Required or
• Master's 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:
• Bachelor's 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
• Bachelor's Degree Engineering or Scientific field with 2 years related work experience Required or
• Master's 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:
• Bachelor's degree in engineering required.
• 2-4 years experience required.