Senior Quality Engineer Job Description
Senior quality engineer
provides guidance to the usage of appropriate risk assessment tools, such as a FMEA, along with development of risk management documents.
Senior Quality Engineer Duties & Responsibilities
To write an effective senior quality engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included senior quality engineer job description templates that you can modify and use.
Sample responsibilities for this position include:
Application of technical principles, theories, concepts and quality sciences, tools and systems with measureable / confirmed results
Assist in the implementation, compliance, and maintenance of standards (e.g., FDA, ISO13485) and OGA Quality policies and procedures
Supports the development of quality engineering and quality compliance with the right skill sets for new process introductions, and asset life cycle management
Responsible for supporting production manufacturing with problem solving, process improvements and resolution to manufacturability issues
Reviews supplier PPAP submissions including control plans and assists with control plan creation where necessary
Participate on APQP and other cross-functional teams and provide input to the requirements for the review and approval of new or modified products, new or modified purchased components and new or modified processes
Provide oversight and guidance to suppliers on non-conformances
Assessing the need for new gages
Review Engineering drawings and changes to assure that they are properly dimensioned and conform to GD&T protocol, and provide proper inspectability for the related component
Review customer rejected hardware to determine cause and corrective action
Senior Quality Engineer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Quality Engineer
List any licenses or certifications required by the position: ASQ, CQE, ISO, CQA, NASA, CQT, AS9100, ISO9001, UK, TS
Education for Senior Quality Engineer
Typically a job would require a certain level of education.
Employers hiring for the senior 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, Technical, Science, Computer Science, Education, Manufacturing, Industrial, Medical, Mechanical Engineering, Management
Skills for Senior Quality Engineer
Desired skills for senior quality engineer include:
ISO 13485
GMP
FDA
Principles
FMEA
SPC
Product/process Risk Management
Theories
Statistical software packages with the ability to preview
Desired experience for senior quality engineer includes:
Experience with testing/automating REST APIs
Proficient in troubleshooting directory services issues with LDAP solutions e.g AD, OpenLDAP, Lotus Domino
Lead quality issues with suppliers & partner with Internal Customers
4-6 years related experience within Regulated Industry
Proven ability to successfully develop new processes and technologies
In-depth knowledge and experience Equipment Qualification and Process Validation
Senior Quality Engineer Examples
1
Senior Quality Engineer Job Description
Job Description Example
Our growing company is hiring for a senior 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 quality engineer
- Apply principles of metrology/calibration, reliability, Computer System Validation (CSV) as required
- Investigate and recommend test architecture and associated infrastructure pieces to support the quality engineering methodology, process, and procedures
- Investigate and recommend testing and automation tools
- Analyze product source code and propose appropriate test strategies for the products
- Participate in product reviews with leadership
- Provides support of Operations, Laboratory, and Quality investigations
- Gathers and performs statistical analysis of quality metrics data to evaluate performance of manufacturing and operations
- Conducts and generates internal audit reports
- Documents and assists in the management of corrective and preventative actions
- Ensures compliance with all Acorda policies and procedures involving the development and commercial manufacturing of drug device combination products
Qualifications for senior quality engineer
- Demonstrated project management and project leadership abilities
- Have 5+ years experience in process quality control in mechanical industry, and supplier quality management skill
- Coursework in Quality Engineering, Statistics, project management, or CQE/ASQ
- Bachelor’s Degree in Engineering discipline or equivalent is required
- Knowledge of basic mechanical testing and material properties is desired
- Knowledge of metrology is necessary
2
Senior Quality Engineer Job Description
Job Description Example
Our growing company is looking to fill the role of senior quality engineer. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior quality engineer
- Leads problem solving teams utilizing 8D methodology
- Leads cross functional team Corrective and Preventive Action (CAPA) activities to drive performance improvements
- Assists in the process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 9001), Advance Problem Solving methods, and that documentation is complete and compliant with requirements
- Design and/or specify inspection and testing procedures/systems for injection molded products to ensure Medivators products conform to specifications and quality standards
- Investigate/analyze in-house and field failures (returns) and monitor quality trends
- Participate in review of injection molding processes to assure validations are current and acceptable
- Participate in development of validation plans for new molding machines and molded components, including scientific molding
- Review and approve disposition for Nonconforming Product and participate in Material Review Board (MRB) team
- Review and approve Engineering Change Orders (ECO), Deviation Authorizations, Qualification/Validation Protocols, Final Qualification Protocol Reports, Inspection Procedures
- Lead efforts to continuously improve molded product quality, while ensuring safety, efficacy and regulatory compliance
Qualifications for senior quality engineer
- Strong leadership capabilities with demonstrated ability to teach mentor and coach
- ASQ certifications in of the following areas is preferred (Certified Quality Engineer (CQE), or Certified Quality Auditor (CQA))
- Statistical knowledge and Minitab experience
- Expertise in programming languages such as Python, Perl, Java, and C
- Domain expertise with storage related technologies, including block level storage and filesystems is required
- Experience with standard software testing methodologies like ISTQB, Agile and waterfall development models
3
Senior Quality Engineer Job Description
Job Description Example
Our innovative and growing company is looking for a senior 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 quality engineer
- Writing and delivering customer focused investigation reports
- Providing verbal communications with customers either over the phone or in person
- Travel to customer location to assist with investigation of quality issues (10-15% travel on average)
- Monitoring incoming customer feedback (complaints) from the field
- Reviewing evaluation findings from Tech Teams for emerging issues
- Providing feedback to customer service, global complaints, design and manufacturing teams, and product managers
- Working with the Medical Device Reporting team as necessary
- Ensuring design and manufacturing sites are aware of emerging and persistent issues experienced in the region
- Serve as Quality Assurance representative for tasks related to regulatory Field Actions in their area of responsibility
- Partner with global software development teams to formulate and successfully implement a comprehensive quality strategy
Qualifications for senior quality engineer
- Bachelor’s degree in in an ABET accredited Engineering discipline is required
- Working knowledge of process validation, test method validation and applied statistics is required
- Bachelor’s degree or equivalent in Electrical Engineering, Quality, or other technical field
- Minimum 5 years of experience in a Quality Engineering role within a complex electronics manufacturing environment
- Must have thorough understanding of problem solving methods, , 8D, root cause analysis, , and the associated statistical tools used to analyze problems
- Knowledge of effective new product development and launch system
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Senior Quality Engineer Job Description
Job Description Example
Our innovative and growing company is hiring for a senior quality 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 engineer
- Direct the completion of quality actions stemming from Design Reviews, DFMEA’s and PFMEA’s
- Provide training and mentoring to promote proper use and understanding of quality tools
- Recommend design, manufacturing or control changes to increase product performance, quality or reliability
- Participate on Material Review Board
- Lead, mentor and train assigned personnel
- Review Customer complaint reports and investigations for validity and assure that they are processed and investigated in compliance with Unit and Corporate policies and procedures
- Maintain good laboratory practices (GLP) consistent with product development objectives and regulatory requirements
- Revise SOPs and enforce compliance with equipment maintenance protocols and hazmat management on behalf of the laboratory team
- Perform qualitative and quantitative analysis and critically analyze data generated
- Ensure systems at workflow preclude lengthy unanswered complaint investigations by making measureable improvements to the complaint handling processes and procedures
Qualifications for senior quality engineer
- Understanding of standards, implementation, and certification process of Quality Management Systems such as AS9100, ISO-9001, or other industry-specific standard or regulation
- Excellent client/server and application troubleshooting skills
- Experience with code coverage analysis and tools such as JCov, Clover, JaCoCo, Bullseye
- Experience testing large relational databases, ability to write custom T-SQL, administer MS SQL Server, and performance fine-tuning skills are a plus
- Experience with BDD and/or TDD (Behavior/Test Driven Development) is a plus
- 5+ years of working experience in Quality Engineering, minimum 3 years in medical device design or manufacturing environment
5
Senior Quality Engineer Job Description
Job Description Example
Our company is growing rapidly and is hiring for a senior 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 quality engineer
- Archive PPAP documents in database and send PSW to supplier
- Ensure compliance to quality manuals
- Establish correlation of raw material attributes and finished product function to improve relevance of purchasing specifications
- Standardize the treatment of non-conforming material
- Coordinate with Technical/Warranty group on response to field complaints for factory defects, making use of current or enhanced field complaint system
- Complete supplier quality audits
- Complete analysis of processing and product parameters to enable production at consistent high quality levels
- Assesses quality performance (or cost-of-quality) using statistical and analytical methods
- Develops and establishes advanced quality systems and procedures, inspection plans, quality performance trends, statistical plans, cost estimates, and technical quality plans for proposals
- Assesses the cost of, and determines the responsibility for, products or materials that do not meet required standards and specifications by performing difficult statistical analyses
Qualifications for senior quality engineer
- Makes decision inefficient manner
- Can present information in various forms and forums, collaborates with peers across functions
- Able to cope with changes and uncertainties
- Ask questions and don’t stop at the first answer
- Brings unpleasant facts to discussion, does not hold back information
- Enjoys working hard and learning when opportunities arise