The Quality Engineer is a pivotal role in the company’s quality and ISO initiatives. This individual will work closely with internal personnel in operations, engineering, regulatory compliance, and field service, while working externally with customers and suppliers as needed. Specifically, this individual will be responsible for becoming Proveris’s ISO 9001:2015 certified quality management system’s champion, conducting quality audits, updating documentation as needed to 2015 standards, and assuring up-to-date employee training on relevant quality procedures. In addition, this individual will be responsible for the company’s regulatory compliance, driving ECO and CAPA processes, incoming inspection, as well as working with manufacturing and engineering personnel in a quality oriented capacity.
Essential Duties and Responsibilities:
ISO - serve as ISO Champion (i.e., responsible for conducting internal audits, SOP maintenance, personnel training on relevant quality procedures, and change implementation).
Responsible for initiating and managing quarterly CAPA effectiveness reviews.
Regulatory Compliance – assume project management role for regulatory requirement projects, and identify and monitor regulatory requirements (e.g. RoHS, etc.).
Provide data analysis and techniques to improve process efficiency within the company’s operations.
Interact with quality suppliers to specify component requirements and provide any root cause corrective actions from suppliers.
Responsible for creating and maintaining incoming/outgoing product and process inspection procedures.
Incoming Inspection – perform incoming inspection as required, create and review incoming inspection procedures, manage the review approval process, and work with manufacturing to ensure incoming inspection procedures are effective and efficient.
Product Management – Tract, review, prioritize and drive product improvements on existing products with Product Management.
Manufacturing – manage and monitor calibration processes and ensure all equipment is calibrated as required.
Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
Review and approve in-process and outgoing test methodologies for Proveris instruments.
Participate in mechanical builds and system level build/test as required.
Work with Purchasing to manage supplier quality metrics and to resolve supplier quality issues with root cause corrective action plans.
Engineering – participate in weekly meetings, create required ECO’s, and provide quality planning for current and future products. Create and drive functional & system testing as part of new product Verification and Validation testing.
Service – Create, review and manage the quality processes related to the company’s servicing activities.
5-8+ years of hands-on quality engineering environment including software and instruments, in an internationally recognized quality management system (i.e. ISO9001, or cGxP) environment.
Proven experience working with low-volume/high-complexity instrumentation intended for use in regulated environments (e.g. cGMP for pharmaceutical products).
Some level of ASQ certification, is desirable.
High level of proficiency with Microsoft Word, Excel, PowerPoint, Visio, Outlook and Mindjet MindManager.
Strong hands-on hardware and software troubleshooting skills.
Excellent time/task management, interpersonal, communications, and writing skills.
“Hands on” personality with a proven ability to work effectively in a focused, team oriented environment.
Proven ability to multi-task in a fast-paced environment.
Attention to detail is a must.
Desire to be part of a growing, fast-paced company.
Strong willingness to learn new skills, systems, and customer requirements.
Education and/or Experience:
Minimum of a Bachelor’s degree or work experience equivalent in an engineering, science or technology oriented discipline.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop; kneel; crouch, or crawl; talk, hear, taste and/or smell. The employee must occasionally lift and/or move more than 20 pounds.
Moderate noise level associated with open office work environment and site conditions.
Have ownership of your own performance and success
Maintain confidentiality at all times in accordance with your signed Confidentiality/Non-Compete Agreement
Maintain a professional demeanor in all interactions
Maintain a professional appearance with attention to clean, appropriate attire and good grooming practices
Promote and practice Proveris’s values and principles
The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. They are not intended to be an exhaustive list of all responsibilities and duties required. The statements are also not intended to be a contract or a limitation of responsibilities.
About Proveris Scientific Corporation
Proveris Scientific delivers truly innovative technologies, services, and deep product knowledge to a worldwide customer base of branded and generic pharmaceutical companies, device manufacturers, CDO/CRO/CMO’s, and regulatory agencies working with orally inhaled and nasal drug products (OINDPs).
Our talented team of engineers, scientists, and service professionals has led the way in developing a more complete understanding of the critical quality attributes affecting the performance of OINDPs, and in effectively controlling them from a testing and patient usability perspective.
Our name says it all: Proveris = Prova + Veritas, to mean “testing the truth.”
Proveris Scientific is committed to quality. Proveris Scientific operates within an ISO9001:2008 certified quality management system that has been third-party certified by TUV Rheinland of North America since 2003.
In this episode, I talk to about the difference between big picture thinking versus a detailed orientated mindset and how to benefit from both in your engineering career. I will detail the benefits of each of these thinking patterns and provide strategies for utilizing both effectively as a technical professional. Engineering Quotes: Here are some […]