Senior Quality Systems Engineer Job Description
Senior quality systems engineer
provides the continual analysis of the of the site’s Quality Management System to ensure full compliance to Regulatory and ISO standards (21 CFR part 820, 21 CFR part 11, ISO 13485, ISO 9001, ESD20.20, etc).
Senior Quality Systems Engineer Duties & Responsibilities
To write an effective senior quality systems engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included senior quality systems engineer job description templates that you can modify and use.
Sample responsibilities for this position include:
Supports the implementation of regulatory standards internal JNJ standards
Will act as an expert resource in external regulations and standards requirement knowledge for cross functional teams
Support China JV Functional teams (SMTs, Program Quality, Design Studios, Supplier Quality and other stake holders) understanding of GCA standards and processes
Leads/supports significant Quality System projects effectively using a working knowledge of project management techniques
Responsible for Complaint Management
Management of Internal Audit Process
Management of Corrective / Preventive Action System
Generation of Quality System Metrics Complaints, CAPAS, Audits
Develop innovative and practical solutions to complex and unique process problems and system improvement through the use of best practices
Develop innovative and practical solutions to complex and unique process problems through the use of best practices
Senior Quality Systems Engineer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Quality Systems Engineer
List any licenses or certifications required by the position: ASQ, QE, ISO9001, ISO, CQE, RAC, MDR, EU, MDSAP, FDA
Education for Senior Quality Systems Engineer
Typically a job would require a certain level of education.
Employers hiring for the senior quality systems engineer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Technical, Manufacturing, Computer Science, Electrical Engineering, Medical, Education, Design, Computer Engineering
Skills for Senior Quality Systems Engineer
Desired skills for senior quality systems engineer include:
ISO 13485
Project management techniques
21 CFR 11
Related disciplines
Statistical methods
ISO and QSR regulations
Standards
Desired experience for senior quality systems engineer includes:
Be a leader of SSG Quality Business Systems upgrades from ISO9001-2008 to AS9100D to focus on consistently meeting customer requirements and enhancing their satisfaction
Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes
Maintain current knowledge of the FDA regulations (frequent reading of the trade press/emails, FDA news bulletins, attending job-related webinars, or outside courses when appropriate)
Any other duties identified by management
Good knowledge and experience with MS Office software - Excel, Word, Powerpoint, Outlook and SharePoint
Good driving skill, more than 3 years actual driving experience
Senior Quality Systems Engineer Examples
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Senior Quality Systems Engineer Job Description
Job Description Example
Our innovative and growing company is hiring for a senior quality systems engineer. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for senior quality systems engineer
- Possess an understanding of web/mobile applications and their integration internally externally
- Possess an understanding of in-vehicle test bench components
- Develop and Produce support of vehicle-related telematics issues
- Remain current with Company internal architecture design strategy
- Support effective management of costs related to Department budget
- Leads teams/projects related to Complaint investigation, CAPA, cost reduction, and quality system excellence
- Revise SOPs and work instructions due to audits, Lean/Improvement projects, and Global Quality System initiative
- Execute change controls that implement new customer specific part numbers and/or artwork changes
- DMR, DHF and Technical File maintenance
- Investigate, close, and trend customer complaints and non-conformances
Qualifications for senior quality systems engineer
- Quality Systems experience in an FDA-related environment is strongly preferred
- Process Excellence (Six Sigma / Lean ) experience is preferred
- Strong knowledge with object-oriented programming languages (Java, C++) and design skills
- Bachelor of Science degree in Mechanical Engineering or Electrical Engineering from an ABET accredited university
- Demonstrate an ability to communicate negotiate with internal/external customers
- Possess an understanding of telematics protocol/interfaces
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Senior Quality Systems Engineer Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of senior quality systems 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 senior quality systems engineer
- Establish standards around QA automation, maintain automation framework and tools
- Support Supplier Management
- Assist with management review/quality metrics data collection, analysis, and presentation
- Provide insight and expertise on quality system processes and to both internal BSC customers working with external partners
- Must be able to apply project management principles and techniques as they relate to quality system planning, implementation and tracking
- Support a team of Analysts and Engineers to perform quality analysis and control for on-going Rail Systems projects and proposals
- Lead the development of a Rail Systems Quality Management System for the Rail Systems Engineering Group with the target to achieve ISO9001 certification
- Prepare Rail Systems Project Management Plans including Safety/Quality Plans, Work Plans, Risk Management Plans, and Communications Plans from a rail systems perspective
- Monitor all Rail Systems hardware and software quality related activities on the projects, and liaison with the client’s Rail Systems Quality Manager on all Rail Systems quality related issues
- Plan and lead project audit reports for current and new projects, including the required rail systems quality, financial, risk, and performance analysis
Qualifications for senior quality systems engineer
- Show an aptitude to acquire knowledge about applicable technologies
- Experience with vehicle communication system tools (CAN, H/W diagnostics tools)
- Thorough knowledge of GMP and Quality Systems required
- Manages vendor partners with accountability for department operations for build and run activities in a SaaS Cloud configuration
- Participates in the development of policies and procedures to achieve department goals, and meet financial targets
- 8+ years’ experience in related Quality management field managing or leading Build & Run Application Support teams
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Senior Quality Systems Engineer Job Description
Job Description Example
Our company is growing rapidly and is hiring for a senior quality systems engineer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior quality systems engineer
- Train and monitor staff in Rail Systems Quality Control, Root Cause Analysis, and Continuous Improvement techniques
- Timely review Rail Systems software development plan, hardware development plan, quality plans, and other project plans to ensure correctness and completeness
- Review and act upon customer complaints, and project and quality performance issues
- Local and international travel to support proposals, projects, and Client’s needs
- Lead and/or facilitate internal and external audits (QMS, CMMI, AS9100, regulatory, customer)
- Selects, develops, manages, and ensures defect-free performance of the business' supplier base with the objective of overall quality improvement
- Participates in supplier evaluation, selection, and strategic sourcing process development
- Responsible for the supplier corrective action process including containment, root cause analysis, and corrective action
- Ensures suppliers use quality tools effectively
- Works with supplier to ensure all product requirements are met
Qualifications for senior quality systems engineer
- Experience within the Quality Management System (QMS) that supports the quality disciplines of Complaints, Non-Conformance, CAPA, Audit, Recalls, Change Management and Document Management that comply with Regulatory requirements is a must
- Ability to define work processes and lead team members in successful implementation and ongoing execution
- Ability to develop individuals along a professional career path
- Formal training in Six Sigma, AS9100 preferred
- Develop and implement world-class Quality System processes in support of the business requirements, working closely with site Quality leaders
- As a site matures (such as moving from component manufacturing to Finished Device manufacturing) lead the development of the site quality system to meet the additional requirements
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Senior Quality Systems Engineer Job Description
Job Description Example
Our company is growing rapidly and is hiring for a senior quality systems 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 senior quality systems engineer
- Define the testing strategies for the QA team through the lens of technology and architecture
- Lead efforts for environment and data set-up, and process documentation
- Work closely with project team members, development and business partners to understand scope of testing requirements
- Participate in all Agile ceremonies
- Provide status, feedback, estimates
- Review and oversee the execution of test plans within the QA team
- Executing test plans and cases including modifying code as needed
- Developing regression strategies and plans to execute them
- Developing requirements analysis and traceability
- Mentors and provides guidance to QA staff
Qualifications for senior quality systems engineer
- Follow team best practices
- Must have a strong understanding and experience with quality, regulatory, and FDA processes within the medical device manufacturing industry
- Experience in gathering requirements, assisting creating the functional specs, and performing in the role of application solution manager
- Ensure all aspects of the sites QMS (Management Reviews, Internal Audits, and Supplier Management ) are in compliance with the global quality procedures
- Represent Quality in customer meetings
- Responsible for scheduling, planning, conducting, communicating and reporting on global internal audit results
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Senior Quality Systems Engineer Job Description
Job Description Example
Our company is growing rapidly and is looking for a senior quality systems engineer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior quality systems engineer
- Removing obstacles for the QA team members
- Ensuring that QA team members deliver according to their responsibilities
- Be able to fill in for Systems QA Manager in their absence
- Be the SME and process owner for global Quality System processes, such as Internal Audits, Management Reviews, and CAPA
- Drive harmonization of QMS processes
- Carry out training on harmonized processes as required
- Help develop the QMS harmonization strategy
- Organize both scheduled and unannounced QMS audits across global sites to ensure regulatory compliance
- Work with cross-functional and cross-site teams to improve quality system processes
- Implement changes to the QMS as driven by internal and external factors
Qualifications for senior quality systems engineer
- Good written and verbal communication skills, the ability to influence stakeholders/partners
- Minimum 4 years of experience in a regulated industry (medical device or pharmaceutical) is required
- Liaise closely with the Project Management Office to be aware of NPI/transfers into the sites that could impact the QMS, and plan for such changes
- Support implementation of Electronic Quality Systems and other systems that could impact the QMS
- Facilitate improvement teams for quality systems
- Evaluate business goals, identify improvement opportunities and apply scientific methods, statistics and problem solving techniques where appropriate to improve and sustain quality system effectiveness