Quality Assurance Professional Job Description
Quality assurance professional
provides support to ensure that quality system activities are conducted in accordance with applicable regulations and standards including, but not limited to ISO (International Organization for Standardization) Standards, and the European MDD (Medical Device Directive)/MDR (Medical Device Regulations).
Quality Assurance Professional Duties & Responsibilities
To write an effective quality assurance professional job description, begin by listing detailed duties, responsibilities and expectations. We have included quality assurance professional job description templates that you can modify and use.
Sample responsibilities for this position include:
Responsibility for identifying all business opportunities within the business unit
Assessing compliance of Sponsor/Investigator/Monitor/Vendor to the protocol, ICH GCP guidelines and all applicable regulations
Documenting/reviewing audit observations and responses
Driving projects to completion in alignment with functional and business strategies
Collaborating with and influencing cross functional teams (e.g., technical, operations, regulatory, document control, maintenance and calibration, environmental monitoring and control)
Colloborating with and influencing cross functional teams (e.g.,technical, operations, regulatory, document control, maintenance and calibration, environmental monitoring and control)
Will be the interface with the customer regarding Quality, Safety and Environmental issues.You will also be included in the overall quality and traffic safety work as a member of the QHSE department
Analyzing identified issues for their impact on capital and other upstream and downstream processes or systems, communicating and escalating observations
Regular liaison with front and middle office employees across EMEA regarding review findings and where appropriate, escalation to senior management
Updates KPIs, metrics, and other presentations
Quality Assurance Professional Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality Assurance Professional
List any licenses or certifications required by the position: CPA, CAMS, CIA, CISA, ISTQB, ISO9001, BMS, ISO, ITIL, ASQ
Education for Quality Assurance Professional
Typically a job would require a certain level of education.
Employers hiring for the quality assurance professional job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Computer Science, Engineering, Education, Science, Medical, Information Technology, Manufacturing, Finance, Business, Life Science
Skills for Quality Assurance Professional
Desired skills for quality assurance professional include:
FDA medical device quality system regulations and ISO medical device industry standards
E1 and PLM systems
Computer programming languages
Databases
Operating systems
Regulations and standards affecting IVDs and Biologics
ERP and PLM systems
Ability to design
21CFR Part 11 and application of predicate rules with respect to clinical processes and systems
Automation scripting software
Desired experience for quality assurance professional includes:
Some knowledge of other professional standards (e.g…HUD, ERISA, SEC, PCAOB or IFRS)
Advanced proficiency in Microsoft Office programs
Ability to work with all levels of the firm
Ability to set and achieve goals while meeting challenging deadlines and requirements
Superior quality in work, with close attention to detail
Ability to work independently, part of a team, on multiple projects
Quality Assurance Professional Examples
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Quality Assurance Professional Job Description
Job Description Example
Our company is looking for a quality assurance professional. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality assurance professional
- Positively and creatively influence department change
- Providing advice and guidance to project staff his/her own team members on QA standard requirements, and working with the project management and staff to address QA related issues
- Review of QA requirements for Procurement
- Advising and working with various teams
- Requirements Analysis, tests case creation and execution, bug reporting and resolution release preparation and production support, all within an agile environment
- Designing and standardize processes for existing new customers according with the global standards
- Creating all needed documentation (working instructions, procedures ) 2nd Level and 3rd level teams
- Searching for future standardization of change using repetitive changes and actions
- Prepare all needed documentations, taking into consideration the quality control documents
- Design, plan, review and execution of test cases
Qualifications for quality assurance professional
- Bachelor's degree in engineering or physical science plus 12 years of experience, or an advanced degree in engineering or physical science plus 10 years’ experience
- Experience in the quality field working in the US Nuclear field either in support of Fuel Fabrication or Reactor manufacturing and operations
- At least 5 years of experience working in Nondestructive Inspection areas specializing in Radiographic, Liquid Penetrant, Visual Inspection and Leak Inspection
- Able to achieve certification as an American Society of Nondestructive Testing Level 3 in the above areas within a reasonable timeframe
- Lead Auditing experience in the nuclear field
- Experience as the customer interface involving external auditors representing organizations regulated by the Nuclear Regulatory Commission
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Quality Assurance Professional Job Description
Job Description Example
Our company is searching for experienced candidates for the position of quality assurance professional. 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 quality assurance professional
- Checking process drawings and process flows for correlation to control plans and customer specifications
- Leading and participating on quality improvement project teams
- Supporting design control projects and teams through the new product development process to ensure proper transfer of products to manufacturing
- Translating requirements, negotiating and compiling PPAP package documents and coordinating submittals to the customer
- Execute reviews of Audit Work papers, Audit Practices processes and programs, Issue Validations including other topical and special projects
- Act as both Manufacturing Engineering and Quality Engineer in the resolution of Quality issues
- Coordinate the qualification of new material with R&D, Operations Engineering and supplier
- Maintain and Analyze Key Performance Indicators and Cost of Poor Quality data to identify recurring trends and drive improvement actions to reduce internal and external failure costs
- Drive Supplier actions to verify part and process quality at the Supplier’s location to reduce the need for incoming inspection activities from Supply chain
- Development of quality plans, general quality agreements, quality requirement specifications
Qualifications for quality assurance professional
- Demonstrated networking and influencing skills
- Sound knowledge of FDA quality system regulations and ISO standards (eg
- Strong data management and MIS production skills to support all aspects of maintenance and improvement of the reporting processes by leveraging various Microsoft tools (like Excel & Access)
- Self-motivated, enthusiastic individual who has experience and interest in risk or control environments
- Bachelor’s Degree in Business Administration, Finance, Accounting and a minimum of three (3) years’ experience in the securities industry as a business analyst or consultant or as an auditor with a certified public accounting firm or an equivalent combination of education, training or experience
- Perception, observation, and attention to detail
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Quality Assurance Professional Job Description
Job Description Example
Our growing company is hiring for a quality assurance professional. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality assurance professional
- Lead supplier audits of new and existing suppliers
- Provides specialized guidance or train support and/or professional staff
- Support the development and winning of new business as part of the company's strategy to grow its footprint both in KSA and abroad
- Assess Suppliers, including on-site audit activities
- Advising various teams (e.g., sterilization, packaging, document control, maintenance and calibration, environmental monitoring and control)
- Execute validation of regulatory and QA-raised issues, reviews of Audit Work papers, reviews of Audit Practices processes and programs and other topical and special projects
- Partnering with labeling team on development and review of artwork and bitmap files
- Ensuring product labels meet procedural requirements for defined regions
- Providing hands-on coordination and support for nonconforming product (NCR) investigations, failure investigations (FIR), and corrective and preventive actions (CAPAs) from initiation to completion to ensure systematic issues are addressed in a timely manner
- Helping packaging, boxing, sterilization, and labeling with daily issues related to quality-system requirements
Qualifications for quality assurance professional
- Experience with very good understanding of V&V and different strategies
- Experience in Integration, load, performance and E2E testing
- Confluence/SharePoint - Information
- CIA, CISA, CPA or CAMS certification desirable
- In-depth understanding of audit methodologies In-depth knowledge of financial services, with ability to evaluate appropriateness of audit results across multiple lines of business
- Ability to document and track defects, produce detailed reports using defect tracking tools
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Quality Assurance Professional Job Description
Job Description Example
Our company is growing rapidly and is looking for a quality assurance professional. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality assurance professional
- Advising various teams (e.g., labeling, sterilization, packaging, document control, maintenance and calibration, environmental monitoring and control)
- Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes, which add value to the business
- Investigates complex complaints
- Provides compliant solutions to a variety of complex problems
- Provides supporting information for change including reasons and justifications
- Participate in the development or modification of validation packages, design plans, and risk management deliverables
- Conducts and reviews deviation investigations related to the manufacturing, packaging, testing of product, sterility assurance, and all other GMP functions
- Evaluates and approves changes to manufacturing and packaging equipment and processes, testing, IT systems and other GMP documents and programs
- Candidate is a member of the work team(s) for B156 or B248, and partners with operations and technical support on continuous improvement projects, floor support needs, and other efficiency improvements
- Structure and execute an efficient and effective approach to managing the internal audit department’s
Qualifications for quality assurance professional
- Extremely organized with high level of attention to detail and ability to follow-through
- Demonstrate ability to work independently and within a team environment
- Using testing techniques, design, develop, analyze test plans and strategies, write and execute test cases, and troubleshoot defects for applications
- Determine integrated testing solutions that include cross dependencies between organizations and programs, develop data and environment strategies utilizing architectural skills and methodology to meet performance, usability, scalability, reliability and security needs
- Responsibilities may include E2E testing which encompasses the entire customer experience including sales, ordering, provisioning, activation, billing, payment processing, and customer service
- Basic ITIL and support know-how
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Quality Assurance Professional Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of quality assurance professional. 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 quality assurance professional
- Triage of new incoming customer complaint tickets
- Tracking and trending of complaint data and systematic evaluations
- Identification of potential quality issues including support of risk assessment vigilance activities
- Ensuring compliant documentation related to area of responsibility
- Support of department specific metrics generation
- Proactive improvement of relevant processes
- Support of the Global PQA Team
- Execute quality assurance (QA) reviews to ensure compliance with department policies and standards, for audit files, risk assessment process and audit closure verification processes
- Assist with production of regulatory requests and liase with auditors and other departments within the Firm to fulfill regulatory requests and followup
- Coordinate requests of regulatory exams of IAD and participate in meetings to support audit documentation
Qualifications for quality assurance professional
- Previews experience in a financial entity
- Knowledge about data security and privacy
- Advanced German language
- Available for regular travel
- 5-7 years quality assurance and lead experience
- Experience working with offshore staff