Senior Design Quality Engineer Job Description
Senior design quality engineer
provides quality engineering support to project teams in compliance with FDA, ISO and CMDR regulations and Ortho Quality System requirements.
Senior Design Quality Engineer Duties & Responsibilities
To write an effective senior design quality engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included senior design quality engineer job description templates that you can modify and use.
Sample responsibilities for this position include:
Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements
Define compliance to Quality System Regulations for global cleanroom environments with frequent interactions with regulatory agencies
Establish cleanroom guidelines that address business needs in partnership with industry organizations (e.g., IEST/ISPE/AAMI) while keeping informed with global guidelines (e.g., ISO/FDA/MDD)
Understand and implement the processes and intent of all aspects of the QMS related to Design Controls
Communicate effectively at all levels within Quality, cross functionally with departments such as Product Development, Regulatory, Manufacturing, and Marketing
Assist in the creation of verification and validation test plans, protocols and reports
Develop full understanding of the product, production process, disease states, therapy application, regulatory requirements and the failure modes typically experienced by the customer
Performs Hardware and Software document reviews, Development Folder, Process Audits, and Prepare review/audit reports
Provides supports and participates in New Contract Proposals/Reviews (RFP/RFQ)
Provides support with Hardware & Software Conformity and First Article Inspections (Hardware & Software), audits by external entities
Senior Design Quality Engineer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Design Quality Engineer
List any licenses or certifications required by the position: ASQ, CQE, ISO, 9001, AOAC, AAMI, CQA, CE, BS, DMAIC
Education for Senior Design Quality Engineer
Typically a job would require a certain level of education.
Employers hiring for the senior design quality 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, Medical, Computer Science, Education, Design, Mechanical Engineering, Electrical Engineering, Biomedical Engineering
Skills for Senior Design Quality Engineer
Desired skills for senior design quality engineer include:
ISO 13485
FDA QSRs
Process and design excellence tools is strongly
Design Controls
Excel
FDA
Quality System Regulations
Design and process control activities
GMP
Desired experience for senior design quality engineer includes:
Masters of Science in molecular biology, chemistry, biochemistry, microbiology, engineering or related discipline preferred
Working knowledge of C and object-oriented programming (Java, C++, ), scripting languages (e.g., Python, PERL, Shell), and LabView
Familiar with Medical Device Software – Software Life Cycle processes
Demonstrate functional knowledge and expertise software development, software lifecycle (SDLC) processes, regulatory requirements, international standards, and risk management
Effectively manage multiple tasks and lead execution of change management plans
Lead or manage the Quality function for design projects, reliability concepts for complex systems, validation planning and statistical sampling, six sigma root cause analysis tools and project management techniques
Senior Design Quality Engineer Examples
1
Senior Design Quality Engineer Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of senior design quality engineer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior design quality engineer
- Performs hands-on Software SOI (Stages of Involvement) audits
- Requires to perform Root Cause analysis investigations and implement Corrective Actions
- Participates in Process and/or Quality Improvement Projects
- Travel to support customer or supplier related business trips, as needed
- Support Engineering quality system/process build up within Chiller Solutions engineering
- Build and continuously improve DFMEA process flow chart (project DFMEA and template DFMEA), roles & responsibility, DFMEA BOS documentation and DFMEA database
- Facilitate to create and review DFMEA’s for Chiller Solutions Product Teams
- Manage the proper linkages between the DFMEA and other processes (CC&SC, PFMEA, Test Plan, Control Plan)
- Facilitate lessons learned from past or ongoing product issues back into Design Rules, DFMEA, Reliability Test Plan and other documents as necessary so as to be considered in future
- Support warranty reduction initiatives by facilitating corrective actions with product engineering teams focused on the resolution of top design attributed warranty issues using advanced statistical analysis, problem solving techniques and Quality tools
Qualifications for senior design quality engineer
- Effectively write communications that ensures clarity, accuracy and consideration of the audience
- Speak with clarity and express points of view in a variety of settings
- Listen to others
- Analyze using systematic analysis tools that include Six Sigma, root cause, failure analysis and risk assessment to gather critical information and diagnose
- Hands on experience with software driven electromechanical devices
- Knowledge on six sigma tools and minimum 1 year of practical experience in using Six Sigma tools
2
Senior Design Quality Engineer Job Description
Job Description Example
Our innovative and growing company is hiring for a senior design quality engineer. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior design quality engineer
- Provide Design for 6 Sigma tools like DOE, DFMEA and Reliability Test Plan training to product team members within the Chiller Solutions organization
- Supports and facilitates Reliability Engineering analysis tools Weibull, MTBF, ALT (accelerate life testing) for new product and components test planning and execution
- Work with design teams to analyze and resolve the issues arising from reliability testing
- Communicate at all levels within Quality cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing
- Provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures medical device regulations
- Provide expert design assurance guidance and support for EMD Millipore product, program, and solution development projects
- Product and process validation planning and support
- Interface and coordinate activities with other quality functions such as manufacturing site quality, quality systems, regulatory affairs, external quality groups, etc…
- Interface with and leverage the entire matrix organization at EMD Millipore in order to best achieve organizational goals
- Participate in new product development projects by providing quality engineering services to assigned projects
Qualifications for senior design quality engineer
- Minimum of a BS in Mechanical, Electrical, or Biomedical Engineering
- Minimum of 5 years of Medical device engineering experience
- A minimum of a Bachelor Degree in Engineering and/or in a Technical Science is required
- An ASQ certification (CQE, CQM, CRE or CQA) is preferred
- Candidate should have a proven track record implementing Quality System improvements to meet compliance and overall business goals
- Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis
3
Senior Design Quality Engineer Job Description
Job Description Example
Our company is hiring for a senior design quality engineer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for senior design quality engineer
- Guide the development of cleanroom construction protocols, reports and evaluate methods in collaboration with intra and inter-departmental teams (e.g., Microbiologists, Quality Engineering, Manufacturing Engineering, Facilities)
- Provide strategic direction and guidance on all global controlled environment projects
- Negotiate and manage contractual agreements with cleanroom construction and/or operations contractors
- Provide expertise for the preparation of risk management plans and documentation for cleanroom and supporting critical utilities including impact assessments, risk analysis, and risk/benefit analysis (e.g., FMEA, FTA, HACCP)
- Standing member of multiple controlled environment standards
- Provide recommendations, identify and gain buy-in from senior management in support of new strategic globalization initiatives, and/or programs involving cleanroom renovation, new construction, and operational best practices
- Using engineering principles, analyze situations or data to identify gaps between project work and the QMS
- Work with product development teams and other QEs to assure compliance to the QMS
- Develop mastery of our products and analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles
- Lead Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects as they relate to Design Assurance and Complaint Review Board Process
Qualifications for senior design quality engineer
- Familiar with statistical software tools (Minitab, Stat Graphics, Statistical), Desirable
- Stability, Biocompatibility, Sterilization, Ship Testing Knowledge, Desirable
- Familiar with IEC 60601, ISO 5361, ISO 5366 and product specific industry standards
- Prior experience with Regulated software development· Effectively manage multiple tasks and lead execution of change management plans
- Performs work under only general direction
- Bachelor's Degree in Engineering or other similar Technical Discipline
4
Senior Design Quality Engineer Job Description
Job Description Example
Our company is growing rapidly and is looking for a senior design quality engineer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for senior design quality engineer
- Lead shelf life and biocompatibility testing and create associated test procedures and reports
- Create and update product risk analyses and risk management files
- Develop and implement new and improved quality/compliant pre-market engineering methods, techniques and processes
- Build stable relationships internally
- Apply statistical methods and process/design excellence tools to establish test plans evaluate test data and processes
- Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials
- Communicate effectively at all levels within Quality, cross functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing
- Serve as primary quality representative on project teams
- Communicate effectively at all levels within Quality, cross functionally with departments such as Research & Development, Regulatory, Manufacturing, Supply Chain, and Marketing
- Produce and review a wide range of quality documents including
Qualifications for senior design quality engineer
- Familiar with quality processes and tools such as APQP, Control Plans, MSA, FMEA
- Strong understanding of industry expectations in the areas such as voice of customer, specification development, risk management, design verification and validation, stability studies, sterilization validation, biocompatibility, transportation testing
- Working knowledge of electro-mechanical devices, software validation methods, and/or plastics related manufacturing processes
- Familiar with gage and inspection techniques
- Fluid verbal and written communication skills
- 4-9 years progressive, seasoned design assurance engineering within the biopharma
5
Senior Design Quality Engineer Job Description
Job Description Example
Our company is hiring for a senior design quality 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 design quality engineer
- Provide Quality System guidance to projects and programs, particularly in product development to ensure compliance to relevant Quality System requirements
- Support or Lead CAPA activities, including root cause analysis, development of corrections and corrective actions, implement changes and monitor effectiveness
- Perform analyses on various types of data, such as post market surveillance, test, process verification or validation to identify trends or other conclusions
- Lead and support software quality engineering activities
- Lead and support software verification and validation activities including protocol development or review and report development and review
- Develop plans for verification and validation of Non – Product software, Software as a Service and Software of Unknown Provenance as they relate to quality system infrastructure and programs
- You are an engineer in the field of bioengineering, medical technology or have a degree in an equivalent subject of study
- Moreover, you are familiar with QSR and have knowledge of Reagents and Assay technology
- You have very good English skills, have had experience in project management and are familiar with the typical MS Office applications
- Build a system ensuring early detection and mitigation of design risks
Qualifications for senior design quality engineer
- Bachelor's degree in related technical area (preferably engineering)
- Full understanding of product and process validation
- Demonstrated capability of applying risk management concepts and tools
- Hands-on experience in the application of quality system standards
- Experienced at working in cross-functional teams
- Knowledge quality and regulatory requirements