Staff Quality Assurance Engineer Job Description
Staff quality assurance engineer
provides guidance / expertise on EU MDR as well as 21 CFR 820 & 21 CFR Part 11.
Staff Quality Assurance Engineer Duties & Responsibilities
To write an effective staff quality assurance engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included staff quality assurance engineer job description templates that you can modify and use.
Sample responsibilities for this position include:
Support I5 and junior testing staff software vendor staff
Develops tests and experiments using valid statistical methods
Design and implement automated test capabilities (strongly advantageous), maintaining the existing automation framework
Manage the suite of regression test scripts to keep them current as the software functionality evolves
Involved in the preparation and execution of non-functional tests, such as security vulnerability testing, performance, load and latency testing, the analysis of the results
Promote and exhibit team-oriented behavior
May supervise and administer specific aspects of the quality system
Leads or participates in internal audits, supplier audits to ensure systems comply with requirements and are effective
Designs and performs Equipment, Process, Software and Test Method Validations
Participates as member of the design team
Staff Quality Assurance Engineer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Staff Quality Assurance Engineer
List any licenses or certifications required by the position: ASQ, SQE, ISTQB, VAP, RBA, CSER, WD, CQA, CQE, CQT
Education for Staff Quality Assurance Engineer
Typically a job would require a certain level of education.
Employers hiring for the staff quality assurance 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, Computer Science, Science, Technology, Math, Technical, Computer Engineering, Medical, Leadership, Mechanical Engineering
Skills for Staff Quality Assurance Engineer
Desired skills for staff quality assurance engineer include:
ISO 13485
JavaScript based testing
With familiarity of the tool set like
CFR 21 Part 820
Open source test automation frameworks
Software Engineering Concepts and Methodologies
VISA business and Payment applications
Biopharmaceutical
CGMP regulations and product lifecycle
Controlled documentation and data systems
Desired experience for staff quality assurance engineer includes:
With Good Personnel Management Skills
With Good sense of urgency
With Excellent analytical and follow-up skills
Leads risk management, validation, sample size, and external standards review and implementation activities
Develops systems and processes that improve product safety
Leads investigation and disposition of nonconforming materials with the Materials Review Board
Staff Quality Assurance Engineer Examples
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Staff Quality Assurance Engineer Job Description
Job Description Example
Our company is hiring for a staff quality assurance 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 staff quality assurance engineer
- Works with a variety of inspection techniques and acceptance sampling plans such as ANSI/ASQ Z1.4, Z1.9 and C=0
- Coordinates the disposition of nonconforming materials with the materials review board
- Reads, writes, and understands specifications and inspection criteria and to apply criteria using appropriate and properly configured inspection tools
- Applies proficient computer skills in the use of Microsoft Office and database applications (such as Oracle and MiniTab)
- Appropriately reuses existing code wherever possible
- Skilled at developing code for other developers to learn from
- Be a part of a Scrum team inclusive of a Software Engineers, Analytics Engineers, User Interaction Design Engineers, Software Architects and Product Owner
- Build automated scripts for testing analytics and applications developed on an
- Provide leadership in the global validation strategy for the Global Supply Chain Valve Network including regulatory risk/mitigation elements related to validation protocols and reports
- Work cross-functionally (R&D, Quality, Regulatory Affairs, and Operations) and globally to identify best practices for writing validation protocols and reports any data gathering and analysis techniques to effect consistency, global harmonization, ease of transfer and efficiency
Qualifications for staff quality assurance engineer
- Effectively represents the QA Project team and develop relationships across multiple internal departments
- Associates degree in equivalent course of study with GPA greater than 3.7
- Bachelor Degree in Engineering or Applied Science
- Prior experience in automated testing of Front end web application developed using JavaScript/HTML5/CSS3 Experience in testing applications built using modern JS - - Frameworks (like AngularJS) using Mocha/Jasmine
- The Senior Test Automation Engineer will lead the effort to build new test frameworks and or extend existing frameworks
- Bachelor/Master in Engineering or Science
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Staff Quality Assurance Engineer Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of staff quality assurance 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 staff quality assurance engineer
- Driving Improvement of Quality and Customer test failures
- Data mining analysis and performs HDD data analysis
- Performs technical support activities related to manufacturing with engineering approaches to effectively respond to each work request in terms of productivity, quality and cost
- Response to customer's specific requested data/information
- Establish reports as customer's requirements
- Coordinate with related departments for customer's Audit/visit preparation, inform and follow up corrective action for all issues
- Coordinate with related department to response on customer's compliant
- Perform customer support periodical internal quality audit
- Participate special task team audit of process quality monitoring
- Support and manage customer audit at sub-tier supplier
Qualifications for staff quality assurance engineer
- Extensive hands-on experience in writing for Medical Device validations and defending work in external audits
- Experience in Mentoring and Coaching young engineers/technicians in validation execution providing feedback when approving protocols and reports
- Proven track record in designing efficient work flow for engineering team ability to develop metrics to clearly demonstrate performance of the team
- Experience in compliance Regulations that apply to Quality, Environmental Health and Safety have knowledge of standards related to equipment design and implementation into global medical device manufacturing plants
- Proven expertise in Microsoft Office Suite, Minitab and manufacturing systems
- A minimum of 8 years of professional experience OR Master’s degree with 6 years of experience OR PhD with 3 years of experience in (include technical skill)
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Staff Quality Assurance Engineer Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of staff quality assurance engineer. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for staff quality assurance engineer
- Responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development
- Manage process and product non-conformances in line with company procedures
- Review, investigate, resolve and report on quality discrepancies
- Monitor, investigate, and report on customer complaints
- Obtain the necessary quality system certifications and licenses
- Lead audit and inspection preparation, resolution of audit and inspection findings
- Frequent interaction with other functional areas and operating entities
- Responsible for firmware validation test efforts of both new Hard-Disk-Drive (HDD) and Solid-state Drive (SSD) Technologies
- Main point of contact and final gate before large scale/volume production
- Develop testing strategies and lead the execution and development of hundreds of tests while balancing system/resource constraints in order to maximize the quality of test efforts
Qualifications for staff quality assurance engineer
- In-depth understanding of manufacturing process quality controls and the ability to document and implement the requirements
- Proficiency with Precision Inspection Tools, Auditing Techniques, and Quality Data Monitoring
- Experience with customer interaction to support customer visits and audits
- Bachelor Degree in Engineering/ Computer Science/ Applied Science
- Minimum 8 years working experience preferably in Quality function
- Knowledge on ISO 9001 Quality System
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Staff Quality Assurance Engineer Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of staff quality assurance 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 staff quality assurance engineer
- Debug any failures encountered using the test scripts, Serial ATA (SATA) specification, ATA/ATAPI Command Set (ACS) specifications, modifying the test scripts, and utilizing equipment like SATA Bus analyzers
- Read and modify test scripts to target test criteria to ensure product and customer standards are met assisting with the creation of new test profiles to test any new features or to modify existing cases to conform to new specifications
- Have the ability to craft detailed test scripts outlining various scenarios, results, and recommendations for failure remediation
- Ability to tackle problems that require extensive data gathering, investigation, review, and analysis to define the problem and then develop/implement solutions which requires the use of complex analytical techniques and creative thinking
- Participate in brainstorm and design sessions with the intent of writing and completing test scripts for the use by any system tester or QA staff member
- May participate in collecting evidence for monthly and quarterly system audits
- Develop a deep understanding of appropriate data & software components including conceptual data models, data flows, entity relationships, specifications, audit controls, exception and error handling, Security
- Collaborate closely with the Product Owner and cross-functional delivery team to deliver high-quality solutions that produce the expected business value
- Build and execute test plans/cases based on requirements and design specifications
- Execute manual and/or automated tests
Qualifications for staff quality assurance engineer
- Proficient as expert representative for presenting QA System to internal and external auditors
- Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred)
- ASQ CQT, CQE, CQA certification preferred
- Six Sigma root cause analysis/problem solving training and experience preferred
- Write test plans, cases, and conditions to ensure test coverage
- Work closely with development, product management, and project management to develop applicable automated testing approaches and strategies
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Staff Quality Assurance Engineer Job Description
Job Description Example
Our innovative and growing company is hiring for a staff quality assurance engineer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for staff quality assurance engineer
- Work with different Business Units to coordinate and test the integrations with Nautilus (OnBase)
- Receive, process and track customer issues
- Receive process and track CSAT (Customer SATisfaction) scores from external customers
- Perform first level FA for received Customer Issues
- Collaborate with In-process QA and other teams (Engineering, Operations, Planning and Logistics, ) for customer issue and CSAT items closure
- Drive closure of CSAT detractors and other customer issues (including feedback/requests.)
- Drive Continuous Improvement of CSAT scores
- Communicate to functional owners on Customer Issues (SIR, feedback, requests, CSAT.)
- Attend regular meetings/interlocks with Customers and Communicate Customer items to Functional Owners
- Communicate requests from Functional Owners to Customers
Qualifications for staff quality assurance engineer
- Having 5-7 years of experience in Data Analysis, Failure Analysis or Quality related field
- A minimum of 8 years of professional experience in software development/testing practices OR Master’s degree with 6 years of experience in software development/testing practices OR PhD with 3 years of experience in software development/testing practices
- Must be willing to work out of an office located in Cincinnati, OH
- Bachelor's degree or higher in any Engineering field
- 5-7 years in Customer Support, HDD Engineering, Quality related field
- Fluent in spoken and written English or other language is preferable