Quality Assurance Engineer II
- Job Title
- Quality Assurance Engineer II
- Job ID
- CARROLLTON, TX 75006
- Other Location
Swiss American CDMO LLC is a topical drug, skincare, wound care, and medical device developing and manufacturing company founded to provide cutting-edge topical skincare technologies to selected markets. Our business strategy consists of development, manufacturing, and superior customer service to contract manufacturing customers worldwide. A strong team approach to serve our customers is the basis of our mantra – “Partnering to deliver service through quality, integrity, and commitment.” Are you passionate about Service Excellence, Results, Integrity, and Leadership? These are the core attributes we are looking for at Swiss-American CDMO, LLC. To see all of the opportunities currently available with Swiss-American CDMO, please follow this link in addition to exploring the opportunity that you have already selected below - www.swissamericancdmo.com/careers.
Quality Assurance Engineer II
The ideal Quality Assurance Engineer III (QAE II) is a mid to senior-level position in Quality Assurance. The QAE II will be able to manage the job requirements with little to no supervision and/or peer coaching. This includes, but is not limited to, implementation of quality management system (QMS) activities both internal and external to site, design control quality assurance activities. The QAE II will participate in the development of processes and procedures to enhance and optimize manufacturing and quality outputs; apply general principles of process engineering to assist in manufacturing process development; and understand equipment design and application.
The QAE II 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.
Essential Duties and Responsibilities include the following, other duties may be assigned:
- Interface directly with customers on day-to-day activities, progress to resolve issues, inspection/audit inquiries, and support completion of compliance program requirements.
- Serve as a technical resource to aid in troubleshooting/resolving production issues.
- Maintain technical expertise and work in a collaborative, cross-functional team.
- 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), re-work Plans, Risk Assessments (RA), and other QMS documentation.
- Provides support to quality, production, and engineering personnel when involved in troubleshooting and process optimization.
- Effectively utilize several root cause analysis, 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. to ensure timely closure of investigations in both nonconformances and corrective actions.
- Provides upgrades to process controls; Uses statistical methods for product and process analysis.
- Mentor, peer coach, and provide guidance to Junior level QAEs.
- Provide recommendations for improvements to the QMS, methods, and equipment.
- Identify and implement opportunities for streamlining processes to ensure product quality and consistency in execution.
- Work effectively with site functions to develop and implement specifications and execute change control/request deliverables.
- Serve as a Lead in Quality System activities such as:
- Change Deliverables
- Procedure execution
- Overall understanding of compliance requirements
- Customer expectations for Cosmetics, Drug, and Medical Device products.
- Take the initiative in mapping out solutions, options as well as adequate follow-up and status reporting.
- Considered a Mid/Senior Level Quality Assurance role.
- Bachelor's degree; Master’s degree is a plus.
- Minimum of 8 years of related work experience.
- Mid/Senior level technical writing skills.
- Process or packaging engineering background preferred.
- Extensive knowledge of Microsoft Office Business Suite; Inventory software; QMS software and efficiently generate charts, trends, and presentations.
- Ability to lift up to 25 lbs.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive annual salary, an extensive benefits package including paid time off, medical, dental and vision benefits, 401K plan with company match, and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning, and culture.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.