The Quality Engineer is responsible for representing the Quality perspective throughout the product development process and through the lifetime of the product. The Quality Engineer will work to ensure that all products produced are in compliance with regulatory and customer requirements and that the manufacturing process is understood. The Quality Engineer will collaborate cross functionally with R&D, Compounding, Packaging, Process Engineering, Production, Supply Chain, and Account Management teams. This role may also have significant customer interaction.
This position will be an integral part of the team. Must have excellent verbal and written communication skills, have the ability to multitask with the ability to prioritize tasks as needed. Manufacturing background preferred but we are willing to train with comparable degree. Knowledge of GMP regulations is preferred.
· Be responsible for all Quality-related aspects of product development and on-going product production. This includes raw material, bulk, and finished goods testing specifications and other customer-specific quality requirements.
· Work closely with the Process Engineer to coordinate and complete product validations, including protocols, summaries, and deviations. Analyze new processes, materials, or equipment changes for validated products for impact on validations.
· Participate in Pilot process to ensure that all departments are informed of any cGMP, FDA, customer, or other quality issues and requirements.
· Collaborate closely with Packaging Engineers, Compounding, and customers to set product standards and determine classification of quality characteristics.
· Assist with DOE (Design of Experiment) activities to understand the quality-critical variables in the manufacturing process.
· Oversee the risks associated with programs by utilizing the FMEA process as well as other risk based analysis tools.
Required Skills and Experience:
· The flow of work and duties performed require above average mental and visual attention.
· The ability to work in a team environment is a must.
· This position requires strong knowledge of processes, process optimization, quality, inspection methods, and standards.
· Proficient in Microsoft Office and other office equipment is required.
· Extremely organized and analytical with relentless attention to detail.
· Able to work in a Scrum framework within which people can address complex adaptive problems, while productively and creatively delivering products of the highest possible value.
· Professional, self-motivated, team player with strong collaboration skills
· Bachelor’s Degree in a scientific discipline desired
This Company Describes Its Culture as:
- Outcome-oriented -- results-focused with strong performance culture
- People-oriented -- supportive and fairness-focused
- Team-oriented -- cooperative and collaborative
This Job Is Ideal for Someone Who Is:
- Dependable -- more reliable than spontaneous
- People-oriented -- enjoys interacting with people and working on group projects
- Adaptable/flexible -- enjoys doing work that requires frequent shifts in direction
- Detail-oriented -- would rather focus on the details of work than the bigger picture
- Achievement-oriented -- enjoys taking on challenges, even if they might fail
- Autonomous/Independent -- enjoys working with little direction
Job Type: Full-time
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Work Location: One location