Quality System Engineer Job Description
Quality system engineer
provides topical knowledge in applicable domestic and international regulations and standards e.g., QSR, MDD, 13485 and CMDCAS.
Quality System Engineer Duties & Responsibilities
To write an effective quality system engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included quality system engineer job description templates that you can modify and use.
Sample responsibilities for this position include:
Establish and maintain quality management system
Establish and maintain internal quality management audit system, quality policy and quality target
Ensure following of document control requirements (Example, which document numbering systems will be used
Establish and maintain quality training material
Instruct general quality management system, quality tool and specified battery quality issue by using training material
Analyze Electronic Controls and Systems to be able to identify strategies and create requirements that improve system reliability and performance using auto-calibration techniques
Analyze Electronic Controls and Systems to be able to identify strategies and create requirements to implement auto-self-test at the system and control level
Collaborate with HW and SW Engineers to translate above mentioned strategies into implementable requirements for Control System Platforms and for individual Electronic Controls
Create communication and training material for Auto Self Test / Auto Calibration requirements and strategies
Consult with multi-functional team to define options and strategies in order to create the best solution
Quality System Engineer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality System Engineer
List any licenses or certifications required by the position: ISO, ASQ, CQE, 9001, CQA, IRIS, DFSS, IATF, QMS, QS
Education for Quality System Engineer
Typically a job would require a certain level of education.
Employers hiring for the quality system engineer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Engineering, Technical, Science, Computer Science, Electrical Engineering, Business, Education, Management, Mechanical Engineering, Industrial Engineering
Skills for Quality System Engineer
Desired skills for quality system engineer include:
CMDR
ISO 13485
MDD
AIMD
JPAL
RDC
SPC
Ability to understand other medical device regulations and standards
DOD and allied partners
Desired experience for quality system engineer includes:
A minimum of 8 years relevant experience or a combination of higher education and relevant experience
Strong ability to work in a cross functional structure
Degree in Chemical/Micro
Statistics and Process capability
English at a business levelCustomer Technical Service
Monitor implementation activities and ensure they are completed as expected
Quality System Engineer Examples
1
Quality System Engineer Job Description
Job Description Example
Our innovative and growing company is looking for a quality system engineer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality system engineer
- Bachelor’s, Master’s, or PhD
- Prepares clearly written business communications, investigation summaries, audit reports
- Understand customer needs and environments
- Author feature test plans
- Write complex and innovative test cases to mimic customer workflows
- Communicate with all stakeholders and team members and provide regular updates
- Help the Lead drive the automation process for all the teams
- Helps internal teams, external partners ,quality management and building quality culture
- Scheduling and hosting regular reviews of quality data including but not limited to
- Analyze System/Sw quality customer requirements (during offer phase)
Qualifications for quality system engineer
- Certified Quality Engineer and Certified Quality Auditor (preferred)
- 0 - 2 years of related work experience in large enterprises required
- Computer Science Master's degree
- Strong experience with Python required
- Bachelors or Master's degree in Quality Management, Engineering, Computer Sciences, or equivalent
- Typically 5 or more years of experience in Quality Assurance
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Quality System Engineer Job Description
Job Description Example
Our growing company is hiring for a quality system engineer. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality system engineer
- Travel as required to complete duties
- Maintains, enforces, and manages a compliant and effective CAPA Process for the activities in scope, for effective and lean structures and documents for Q&R processes at all levels including CAPA compliance to regulations and standards ensured through proactive support and facilitation of the CAPA activities with individual CAPA owners
- Ensure the adequacy of Quality Management System procedures to support the complaint handling program
- Generate and evaluate customer complaint related metrics, establish appropriate baselines and demonstrate continuous improvement results
- Support global review of complaints and service costs and service metrics
- Lead functional teams in developing solutions for quality related issues and seeking new opportunities for continuous improvement
- Responsible for implementation of quality management system requirements as directed by the Quality Assurance Manager
- Responsible, on request, for assisting in preparing the internal quality audit schedule covering activities of the PMC team, contractors and key suppliers
- Monitor the effectiveness of the quality system by conducting audits in accordance with the audit schedule
- Responsible, on request, for assisting in the implementation of continual improvement activities on projects and on corporate functions
Qualifications for quality system engineer
- Technical writing expertise and aptitude to understand other technical information
- Excellent written and verbal skills to communicate routinely electronically or via phone with cross functional team members
- Ability to work in shifts, morning, evening and night shifts
- Ability to multi-task and manage multiple work streams at one time
- Problem solving skills and an ability to respond and adapt to change is desired
- BS in Engineering/Technical field, preferred degree in technical writing
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Quality System Engineer Job Description
Job Description Example
Our company is searching for experienced candidates for the position of quality system engineer. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality system engineer
- Assist in compiling documentation following lessons learnt workshops and in submitting it to the client
- Follow up on the audits / reports with the package Quality Managers to ensure compliance to the agreed audit schedule
- Provide induction to new staff on the Company’s QMS
- Carry out occasional site visits to follow up on non-conformances or to carry out audits on contractors
- Execute day-to-day document and engineering change requests
- Open, monitor, and track performance for all CAPAs
- Review documentation (records, procedures, work instructions, forms ) to ensure that it is accurate, complete, and compliant with the process and requirements of the quality management system / GMP
- Direct Gigafactory EPC team disciplines (mechanical, process, electrical, CSA) to effectively produce robust designs for key innovative systems and drive process improvements through quantitative analysis
- Analyze operational performance of equipment designs and recommend key improvements for future factory phases
- Develop Key Performance Indicators for factory equipment and systems
Qualifications for quality system engineer
- 3-5 years of technical experience, 1-3 years in medical device industry preferred
- Assist with implementing and maintaining a single worldwide Quality Management System (QMS) strategy
- Support the business during internal and external audits
- Implement, maintain, and/or improve the quality system to meet or exceed regulatory and ISO compliance and conducts training as appropriate
- Provide periodic updates and escalations on Document Control matters
- Responsible for the creation, maintenance and integrity of the Quality System, Procedures and Forms
4
Quality System Engineer Job Description
Job Description Example
Our company is looking to fill the role of quality system engineer. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality system engineer
- Act as point of contact for operations and external customer feedback loop by understanding design deficiencies and rectifying quickly
- Work with R&D teams to identify and push forward system improvements to better economies of scale, increase throughput, and reduce construction time of Gigafactory systems and products
- Accountable for design robustness and completion of reliability analysis
- Provide support to manufacturing, engineering, supply chain, HR and sales support
- Develop training for the staff of the quality department
- Effectively utilize personal influence to accomplish preventive and corrective action through management
- Monitor, review, conduct and approve quality audits
- Develop working relationships with operators, engineers, managers and other personnel
- Maintain industry contacts within the company and professional organizations to share product and process information
- Attend industry seminars and trade shows, as available and as specified
Qualifications for quality system engineer
- Must have very effective communication skills, organization, and customer service skill
- Proven ability to lead a team and influence others
- Collaborate with system controls and cloud project teams to develop qualification plans, validate test results and manufacturing quality
- Conduct design and manufacturing quality events
- Create quality plans and review/approve quality deliverables
- 4-7 years of experience in quality assurance for development of software, controls, network and cloud-based systems
5
Quality System Engineer Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of quality system engineer. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality system engineer
- Coordinate interactions with external auditing agencies
- Performance of Quality System internal audits
- Qualification of auditors for the facility
- Management of the internal audit process
- Performance of supplier audits for new suppliers and reevaluations
- Management of the Supplier Approval process
- Management of Corrective and Preventive Action system
- Provide Quality Management System training for the facility
- Coordination and development of Management Reviews
- Coordination with Registrar on ISO certification audits
Qualifications for quality system engineer
- 2+ years of experience with AWS (Amazon Web Services), Microsoft Azure and residential router protocols (ZigBee) in cloud-based systems
- 2+ years of embedded firmware-based control systems experience
- Experience with Advance Product Quality Planning (APQP), FMEA, Software Quality Assurance (SQA) concepts, practices, testing tools and methodologies
- Experience with UTC’s New Product Development Process
- Basic electronics, understanding board schematics, using Allegro viewer
- High speed board testing & qualification activities like DVT