Quality Assurance Engineer II

Swiss American CDMO•Carrollton, TX

About The Position

Quality Assurance Engineer II (QAE II) is the mid-level position as a Quality Assurance Engineer. The QAE II will be able to manage the job requirements with limited supervision and/or peer coaching. This includes but is not limited to, quality system activities both internal and external to site, design control quality assurance activities and provides investigational support for NCR’s, CAR’s and customer complaints. The QAE ll will also assist with developing a stable, innovative and compliance focused quality assurance team while working effectively and cross-functionally to meet customer requirements, trouble-shoot manufacturing problems, as well as provide management support to meet Site objectives.

Requirements

Bachelor's degree in Engineering, Science, or a related field from an accredited institution.
Minimum of 5 years of relevant experience in Quality Assurance within a regulated environment (e.g., pharmaceutical, medical device).
Strong understanding of Quality Management Systems (QMS) principles and regulations (e.g., FDA, ISO, GMP).
In-depth knowledge of statistical methods (e.g., probability, statistics, control charting).
Proficiency in risk assessment methodologies.
Experience with data analysis and interpretation.
Excellent written and verbal communication skills.
Ability to effectively communicate complex technical information to various audiences (e.g., management, clients, regulatory agencies).
Strong interpersonal and collaboration skills.
Strong analytical and problem-solving skills with the ability to identify root causes and develop effective solutions.
Ability to interpret and analyze data to identify trends and make data-driven decisions.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Experience with QMS software and other relevant software tools.

Nice To Haves

Master's degree in a relevant field is a plus.

Responsibilities

The QAE will participate in Quality activities.
Interfacing with customers, suppliers and other internal personnel to perform the required implementation of Corrective and Preventive actions, when necessary, also use risk assessment methodologies for written reports.
Assuring GMP and Quality System compliance by reassuring compliance of standard operating procedures
The QAE ll will be capable of handling 4-7+ clients, prospects and/or leads – with limited supervision/assistance.
Create and execute problem-solving and process improvement initiatives with manufacturing, CPMs/PMs and customers to eliminate or reduce issues or failures.
Analyze and appropriately prioritize demands, task assignments, investigation activities, risk factors, and data analysis to meet Site Objectives, Customer requirements and Quality/Compliance initiatives.
Initiate, Write, Review and Manage Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), Rework Plans, Risk Assessments and other QMS documentation.
Write and approve product and process changes and new documents through the site Change Management process.
Effectively utilize several root cause analyses, data analysis and problem-solving techniques such as 6M, Fishbone, Is/Is Not, 5WHYs, Statistical analysis with Qualitative and Quantitative data (variable and attribute data sets), Process Control Charts, Standard Deviation, Statistical Sampling Plans and AQL criteria as well as risk assessment methodologies etc.
Drive corrective action to facilitate improvements and train personnel on Quality and procedure requirements.
Work effectively with site functions to develop and implement specifications and execute change control/request deliverables.
Effectively utilize SA software (uniPoint, ProcessPro, Laserfiche etc.), statistical techniques, and tracking/trending tools (e.g. Excel, Word, Pivot Tables, Power Point, Project Management tools) to collect and analyze data (electronic and manual), create charts and trend reports, create power point presentations on performance as well as effectively present the data analysis.
Lead in Quality System activities such as: Provide recommendations for improvements to the quality system, methods and equipment.
Identify and implement opportunities for streamlining processes to ensure product quality and consistency in execution.
Coordinate/Execute data collection and analysis in operations and validation studies.
Support Quality Management in ensuring consistency in handling and writing of NCRs, CAPAs, Risk Assessments, Change Deliverables, procedure execution and overall understanding of compliance requirements, regulatory and customer expectations for Cosmetics, Drug and Medical Device products.
Ensure consistency, compliance and understanding in the use of SA’s electronic systems.
Take the initiative in mapping out solutions, options as well as adequate follow-up and status reporting.
Other duties may be assigned