Advanced Quality Engineer Job Description
Advanced Quality Engineer Duties & Responsibilities
To write an effective advanced quality engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included advanced quality engineer job description templates that you can modify and use.
Sample responsibilities for this position include:
Advanced Quality Engineer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Advanced Quality Engineer
List any licenses or certifications required by the position: ASQ, AS9100, CQE, APQP, CE, SAQP, CMQ/OE, DFSS, CSQE, TS
Education for Advanced Quality Engineer
Typically a job would require a certain level of education.
Employers hiring for the advanced quality engineer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Engineering, Science, Education, Technical, Mechanical Engineering, Manufacturing, Automotive, Mathematics, Chemistry, Industrial
Skills for Advanced Quality Engineer
Desired skills for advanced quality engineer include:
Desired experience for advanced quality engineer includes:
Advanced Quality Engineer Examples
Advanced Quality Engineer Job Description
- Prepare and communicate supplier APQP workbooks, Tooling Status reports and Open Issues lists (as appropriate) to the program team
- Serve as core team member on new product development / 3P teams
- Develop and ensure that program goals including quality and reliability are met in compliance with specifications and standard work
- Identify gaps and create closure plan for quality and reliability targets
- Utilize various tools to evaluate the effectiveness of AQP including Gemba, management reviews, internal audits, feedback from internal and external customers, warranty data, and traceability
- Lead teams/projects related to compliant investigation, CAPA (especially systems root cause and corrective action), cost reduction, and quality system excellence
- Lead Risk Management activities for low volume customer-specific instruments and implants
- Support design, development and manufacturing of robotic systems, software and instruments
- Develops Quality Assurance Plans for new products
- Lead risk management activities for robotics by developing risk management plans/reports, conducting risk reviews, verifying implementation and effectiveness of risk controls and driving post market activities
- Mechanical or Electronics Engineer
- Must be able to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerance
- Bachelor Engineering Degree (Mechanical Engineering, Manufacturing Engineering, Electrical Engineering or Materials Science or equivalent)
- Partner with engineering to define design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria
- Complete or contribute to the completion of final design verification and design validation test reports by providing clear concise conclusions with statistical validity and graphical support when necessary
- Utilize standard statistical analysis and problem solving techniques as necessary to determine product acceptance limits, establish process parameters, resolve quality problems
Advanced Quality Engineer Job Description
- May coordinate the activities of Quality Control Inspectors and/or technicians
- Generation of a Top 5 list and implement additional action’s
- May direct work of Engineer or Sr
- Responsible for overseeing the daily work operations and providing supervision to a unit or work-group
- Participates in the establishment of unit objectives, work plans, schedules, and ensures resources are available for completion of assignments
- Supervises daily activities of subordinates to ensure assigned tasks are completed in accordance with time and budget constraints
- Provides technical direction/guidance to staff as required
- Resolve technical and/or operations issues to ensure established schedules are met
- Resolves technical and/or operations issues to ensure established schedules are met
- Report any issues / risks to the Lead Advanced Quality Engineer or Simultaneous Development Team / Program Manager
- Bachelor’s degree in Mechanical Engineering or related field of study
- 3+ years of experience as a Quality Engineer (QE) in a regulated design environment
- Competent with Microsoft Office (Outlook, Excel, Word)
- ASQ CQI, CQE, CRE, or P.E
- Strong Statistical Knowledge (SPC,DOE, CPk)
- 3-5 year minimum in Quality Assurance or related functional area such as Design Transfer/Manufacturing Transfer
Advanced Quality Engineer Job Description
- Visit suppliers for Process Sign off events
- Raise Deviation Authorisations for discrepancies when required
- Attend Simultaneous Development Team meetings and provide required quality documents per program timing as needed
- Facilitate/participate in Engineering Design Reviews of specifications and drawings related to the components and develop the action plans to resolve issues
- Assist/support Quality Engineer, as needed, kick-off meetings and process sign-off
- Responsible for suppliers Product- and Process Sign-Off
- Establish and track tooling status and timing
- Report impact of changes and delays to YFAI Program team
- Manage Supplier Quality related activities for purchased materials for electro-mechanical commodities such as printed circuit board assemblies (PCA’s), power supplies, cables, battery packs, plastics, sheet metal, machined parts, OEMs (displays, medical assemblies), labeling
- Ensure supplier management strategy aligns with quality goals
- Perform audits and appraisal
- Bachelor’s degree in mechanical engineering or related discipline, Professional certification (CPM, APICS, Six Sigma, CQM, PE, ) is preferred
- Ability to travel local and internationally up to 30% of the time
- Demonstrated knowledge of FDA QSRs, ISO 13485 Design Control Procedures and ISO 14971
- Minimum of 5 years’ experience in manufacturing, design, quality or supply chain
- Professional certification (CPM, APICS, CQM, PE, ) is a plus
Advanced Quality Engineer Job Description
- Support key processes as subject matter expert
- Working with global functions and sites to deploy continuous improvement and cost reduction initiatives using the application of Informed Decision Making, Quality and Quality by Design principles
- Represent the Global Pharma Quality organization as a Subject Matter Expert for statistical analysis
- Escalate DtV and Combination product issues related to statistical methods to Quality Management (QM)
- Assist with DtV and Combination product related regulatory visits, corporate audits and vendor audits and provide follow up on regulatory commitments
- Ensure/drive internal consistency in nature of relationships and interactions with project teams
- Develop and deliver training for statistical methods (virtual and in person)
- Apply intensive and diversified knowledge of statistics to broad areas of the Janssen Supply Chain decision making processes
- Plan, develop, coordinate, and direct global initiatives number of sub-projects with many complex features
- Contribute to the development of new or improved techniques or procedures related to the statistical tools and business processes used within JSC
- Closed-toe shoes must be worn on the production floor
- Bi-lingual (English, Czech required)
- Preferred 2-3 years experience in field of specialization
- Knowledge of statistical concepts, problem solving methodology is required
- Knowledge and experience in Lean Manufacturing methods is desirable
- Previous experience with metal components and processes (eg stamping) is highly desirable
Advanced Quality Engineer Job Description
- Facilitate deployment of APQP essentials of DFMEA/PFMEA/ PCP/PAPSO/MSA across those projects in PDP and manufacturing locations
- Perform periodic process audits at manufacturing locations & design centers to ensure conformance and compliance to PDP, APQP & GQMS
- May direct and/or evaluate the activities of Advanced Quality Engineering technicians, Associate Advanced Quality Engineers, Advanced Quality Engineers, or Sr
- Perform data analysis, organizing and analyzing data from multiple sources, to identify top issues or potential root causes
- Work with plant personnel to recommend, validate and implement proposed solutions
- Verify corrective actions implemented through data analysis
- Proactively monitor trend charts and work with cross functional teams to drive variation reduction of critical product and process characteristics
- Carry out supplier validation audits, with supplier and supply chain support
- Define new supplier manual standards and supplier quality plan
- Support new product launches to ensure that supplier quality meets the required standards
- Experience working directly with suppliers, particularly automotive related
- University grade of mechanical engineering or a similar education
- Minimum 2+ years’ experience in a relevant Quality function, within the automotive industry
- English and German language is a MUST - Fluency in reading, writing and speaking
- High level of flexibility for travel
- Universal degree in Engineering discipline or equivalent