Quality Assurance Engineer

Quality Assurance Engineer I

Swiss American CDMO

The Quality Engineer (QAE I) coordinates and maintains the Quality Assurance activities required for Swiss American to work effectively and cross-functionally to meet customer requirements. This includes but is not limited to quality system activities both internal and external to site, providing investigational support for Change Controls Non-Compliance Reports, and CAPA’s as applicable as well as authoring QA Documentation as needed.

The QAE I will also assist with trouble‑shooting manufacturing problems, as well as provide management support to meet Site objectives.

• Roles within this listing may be “shadow” roles coached by experienced QA Engineers until proficiency is demonstrated.
• Capable of providing Quality Assurance support and expertise for 1-3 clients, prospects and/or leads.
• 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.
• Assist with CAPA Coordination activities, i.e. Corrective and Preventive Actions, implementation plans, CAPA meetings, etc.
• Assist with bi‑annual reviews of Standard Operating Procedures (SOPs), including their creation, revision, and approval to ensure accuracy, relevance, and compliance.
• Support the Validation activities with execution and documentation as needed.
• Initiate, Write, Author, Review and Manage Quality Documentation as needed i.e. Non‑Conformance Reports (NCR), Rework Plans, Risk Assessments, Validation Protocols, and other applicable documents and routing via the QMS software.
• Effectively utilize several root cause analyses, data analysis and problem‑solving techniques such as 6M, Fishbone, Is/Is Not, 5
  
  WHYs, 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.
• Work effectively with site functions to develop and implement specifications and execute change control/request deliverables.
• Effectively utilize SWISS & MS Office software (uni Point, Deacom, Laserfiche, 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.
• Other duties may be assigned by the Manager.

• Bachelor's degree in Science, Engineering, or a related field preferred.
• Minimum of 2 years of experience in a manufacturing environment.
• Excellent written and verbal communication skills.
• Ability to effectively communicate technical information to various audiences (managers, clients, regulatory agencies).
• Ability to write clear, concise reports, procedures, and technical documentation.
• Strong analytical and problem‑solving skills with a focus on data analysis.
• Proficiency in statistical concepts, including probability, frequency distributions, and control charting.
• Familiarity with risk assessment methodologies.
• Ability to analyze complex data, identify trends, and draw valid conclusions.
• Strong problem‑solving and decision‑making skills.
• Ability to interpret and apply various instructions and regulations.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Experience with Quality Management Systems (QMS) software.
• Ability to generate charts, trends, and presentations effectively.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable…