Quality Assurance Engineer
- Job Title
- Quality Assurance Engineer
- Job ID
- CARROLLTON, TX 75006-6623
- Other Location
Swiss American CDMO LLC is a topical drug and medical device manufacturing company founded to provide cutting-edge topical skin care 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.
Quality Assurance Engineer
The Quality Engineer coordinates and maintains the Quality Assurance activities required for Swiss American Products. This includes but is not limited to process/product/equipment/Sterilization validations, 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.
Essential Duties and Responsibilities include the following. Other duties may be assigned:
- Support product development by assisting the Engineering, Supply Chain, Operations and contract manufacture groups as a team player with an occasional role as the team lead in projects.
- Function as the Quality Assurance representative for the review and approval of CAPA, validations, component and design change activities.
- Assure GMP and Quality System compliance by revising our validation, supplier quality and quality systems procedures as required by our standard operating procedure.
- Interface with customers, suppliers and other internal personnel to perform the required implementation of Corrective and Preventive actions when necessary.
- Issue periodic reports by developing plans for collecting, summarizing, and reporting on required validations, supplier audits quality systems and CAPA effectiveness.
- Initiate product retention request to quarantine component/product in conjunction with the Quality Management team per applicable procedure.
- Conduct engineering change review, design reviews, and material review board activities according to applicable procedures.
- Manage and participate in Quality System activities such as:
- GMP training for new and existing employees.
- GMP awareness program.
- Promotion of the quality system.
- Compliance to domestic and international regulations.
- Manage and participate in the Internal and External Audit programs by conducting audits, writing audit reports, distribution of reports and associated non-conformances, follow-up on designated timelines, etc.
- Act as a team player completing other duties as requested by the Quality Manager or as needed to facilitate the goals for the organization.
- Assist contract customers as required to perform Quality or Quality Engineering support on projects.
- Act as support for site and vendor third-party audits (FDA, Notified body, EPA, State etc).
- Act as the internal reviewer on Quality systems, specs and change control.
- Bachelor's degree from 4-year college or university; or 1 - 2 years related experience and/or training; or equivalent combination of education and experience.
- Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis.
- Knowledge of Microsoft Office Business Suite; Inventory software; Internet software and Manufacturing software.
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.